Medical device manufacturer
Em Diagnostic Systems, Inc.
Em Diagnostic Systems, Inc. holds 288 FDA 510(k) clearances across 74 product codes. Median elapsed review time is 43 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 288
- Product codes
- 74
- Median review
- 43 days
- Recall records
- 0
How does FDA spell Em Diagnostic Systems, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Em Diagnostic Systems, Inc. file in?
74 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 21 | 63 days | |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 14 | 35 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 13 | 37 days | |
| CEK | Biuret (Colorimetric), Total Protein | 10 | 35 days | |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 10 | 32 days | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 10 | 18 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 10 | 35 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 10 | 49 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 10 | 49 days | |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 10 | 43 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 10 | 55 days | |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 10 | 40 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 9 | 43 days | |
| CIX | Bromcresol Green Dye-Binding, Albumin | 9 | 38 days | |
| CFR | Hexokinase, Glucose | 7 | 50 days | |
| CIC | Cresolphthalein Complexone, Calcium | 7 | 43 days | |
| JFJ | Catalytic Methods, Amylase | 7 | 49 days | |
| JGJ | Photometric Method, Magnesium | 7 | 43 days | |
| JIY | Photometric Method, Iron (Non-Heme) | 7 | 50 days | |
| KHS | Enzymatic, Carbon-Dioxide | 7 | 65 days | |
| DLJ | Calibrators, Drug Specific | 6 | 28 days | |
| KNK | Acid, Uric, Uricase (Colorimetric) | 6 | 27 days | |
| CDO | Acid, Uric, Uricase (U.V.) | 4 | 41 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 20 days | |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 3 | 22 days |
Showing the 25 they file in most, of 74.
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 Em Diagnostic Systems, 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 Em Diagnostic Systems, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | CIT | 93 | |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | CKA | 79 | |
| K935179 | EMDS ALBUMIN (ALB) TEST | CIX | 52 | |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | CEO | 52 | |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | JQB | 51 | |
| K935176 | IRON TEST | JIY | 50 | |
| K935175 | LACTATE DEHYDROGENASE (LD) | CFJ | 50 | |
| K935174 | TOTAL PROTEIN TEST (TPRO) | CEK | 50 | |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | CHH | 49 | |
| K935183 | EMDS MAGNESIUM (MG) TEST | JGJ | 43 |
Source: openFDA device/510k · retrieved
Watch what Em Diagnostic Systems, Inc. files next
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