Medical device manufacturer
Wako Chemicals USA, Inc.
Wako Chemicals USA, Inc. holds 123 FDA 510(k) clearances across 58 product codes. Median elapsed review time is 52 days. openFDA lists 3 recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 123
- Product codes
- 58
- Median review
- 52 days
- Recall records
- 3
How does FDA spell Wako Chemicals USA, Inc.?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Wako Chemicals USA, Inc. | device/510k | normalised |
| Wako Chemicals USA, Inc. | device/recall | normalised |
| Wako Chemicals, USA Inc | device/recall | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Wako Chemicals USA, Inc. file in?
58 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | 15 | 21 days | |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 9 | 30 days | |
| JIS | Calibrator, Primary | 7 | 64 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 49 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 35 days | |
| KNK | Acid, Uric, Uricase (Colorimetric) | 4 | 27 days | |
| CEK | Biuret (Colorimetric), Total Protein | 3 | 118 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 39 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 | 64 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 95 days | |
| JFM | Enzymatic Method, Bilirubin | 3 | 52 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 44 days | |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 2 | 34 days | |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | 56 days | |
| CFR | Hexokinase, Glucose | 2 | 63 days | |
| CGA | Glucose Oxidase, Glucose | 2 | 79 days | |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 2 | 40 days | |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 14 days | |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 50 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 | 30 days | |
| CZP | Iga, Antigen, Antiserum, Control | 2 | 29 days | |
| DCN | System, Test, C-Reactive Protein | 2 | 29 days | |
| DEW | Igg, Antigen, Antiserum, Control | 2 | 61 days | |
| DHR | System, Test, Rheumatoid Factor | 2 | 82 days | |
| JFJ | Catalytic Methods, Amylase | 2 | 51 days |
Showing the 25 they file in most, of 58.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Wako Chemicals USA, Inc. had a recall?
openFDA lists 3 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1377-2012TerminatedDFC
In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
Z-1071-2007TerminatedJIT
Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
Z-1409-06TerminatedMMY
Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Wako Chemicals USA, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | NSF | 370 | |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | LBS | 183 | |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | CFR | 182 | |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR | JFY | 245 | |
| K062368 | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 | OAU | 170 | |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | JFM | 52 | |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | JFM | 52 | |
| K042551 | MULTI-CHEM CALIBRATOR A | JIX | 57 | |
| K042550 | MULTI-LIPID CALIBRATOR | JIX | 49 | |
| K042549 | MULTI CHEM CAL B | JIX | 49 |
Source: openFDA device/510k · retrieved
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.