Medical device manufacturer
Sigma Diagnostics, Inc.
Sigma Diagnostics, Inc. holds 164 FDA 510(k) clearances across 95 product codes. Median elapsed review time is 55 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 164
- Product codes
- 95
- Median review
- 55 days
- Recall records
- 0
How does FDA spell Sigma Diagnostics, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Sigma Diagnostics, Inc. file in?
95 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 8 | 86 days | |
| LJG | Quality Control Slides | 7 | 28 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 5 | 25 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 | 28 days | |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 4 | 36 days | |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 | 22 days | |
| GJT | Plasma, Coagulation Factor Deficient | 4 | 137 days | |
| CFR | Hexokinase, Glucose | 3 | 99 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 42 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 30 days | |
| DLJ | Calibrators, Drug Specific | 3 | 55 days | |
| GGN | Plasma, Coagulation Control | 3 | 23 days | |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 3 | 37 days | |
| JIT | Calibrator, Secondary | 3 | 59 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 55 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 | 50 days | |
| KXT | Enzyme Immunoassay, Digoxin | 3 | 55 days | |
| CDO | Acid, Uric, Uricase (U.V.) | 2 | 40 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 25 days | |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 54 days | |
| CGA | Glucose Oxidase, Glucose | 2 | 25 days | |
| CJY | Azo Dye, Calcium | 2 | 37 days | |
| DIH | Colorimetry, Cholinesterase | 2 | 28 days | |
| DKC | Alcohol Control Materials | 2 | 48 days | |
| GFO | Activated Partial Thromboplastin | 2 | 117 days |
Showing the 25 they file in most, of 95.
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 Sigma Diagnostics, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Sigma Diagnostics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | JPA | 141 | |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | GGC | 26 | |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | DAP | 63 | |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | DAP | 22 | |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | DAP | 22 | |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | LCP | 88 | |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | JIX | 25 | |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | GGO | 64 | |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | DAP | 148 | |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | GGC | 128 |
Source: openFDA device/510k · retrieved
Watch what Sigma Diagnostics, Inc. files next
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