Em Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 288 510(k) clearances under the applicant name “Em Diagnostic Systems, Inc.” (first 1984, latest 1994), across 74 product codes in 5 review panels. Median 510(k) review time under this name: 43 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 21 | 21 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 14 | 14 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 13 | 13 |
| CEK | Biuret (Colorimetric), Total Protein | 10 | 10 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 10 | 10 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 10 | 10 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 10 | 10 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 10 | 10 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 10 | 10 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 10 | 10 |
Plus 64 more product codes.
Review panels
- Clinical Chemistry (254)
- Clinical Toxicology (28)
- Hematology (4)
- Ear, Nose and Throat (1)
- Immunology (1)
Most recent Em Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | CIT | 1994-01-27 | 93 |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | CKA | 1994-01-13 | 79 |
| K935179 | EMDS ALBUMIN (ALB) TEST | CIX | 1993-12-17 | 52 |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | CEO | 1993-12-17 | 52 |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | JQB | 1993-12-16 | 51 |
| K935176 | IRON TEST | JIY | 1993-12-16 | 50 |
| K935175 | LACTATE DEHYDROGENASE (LD) | CFJ | 1993-12-16 | 50 |
| K935174 | TOTAL PROTEIN TEST (TPRO) | CEK | 1993-12-16 | 50 |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | CHH | 1993-12-16 | 49 |
| K935183 | EMDS MAGNESIUM (MG) TEST | JGJ | 1993-12-09 | 43 |
278 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Em Diagnostic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Em Diagnostic Systems, Inc.?
FDA lists 288 510(k) clearances under the applicant name “Em Diagnostic Systems, Inc.” (first 1984, latest 1994), across 74 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Em Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Em Diagnostic Systems, Inc. is 43 days.
Which FDA product codes appear under Em Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 21); CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 14); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 13).
Next steps
- See all 288 Em Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Em Diagnostic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.