Emd Chemicals, Inc.: FDA filings under this applicant name
FDA lists 62 510(k) clearances under the applicant name “Emd Chemicals, Inc.” (first 1982, latest 2004), across 35 product codes in 6 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 5 | 5 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 4 | 4 |
| JIS | Calibrator, Primary | 4 | 4 |
| CFR | Hexokinase, Glucose | 3 | 3 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 | 3 |
| JIT | Calibrator, Secondary | 3 | 3 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 3 | 3 |
| LFR | Glucose Dehydrogenase, Glucose | 3 | 3 |
| CDO | Acid, Uric, Uricase (U.V.) | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
Plus 25 more product codes.
Review panels
- Clinical Chemistry (47)
- Pathology (4)
- Clinical Toxicology (4)
- Microbiology (3)
- Hematology (2)
- Immunology (1)
Most recent Emd Chemicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031367 | DUOPATH VEROTOXINS GLISA TEST | GNA | 2004-01-23 | 268 |
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | DNN | 1999-03-31 | 41 |
| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | DLJ | 1998-07-22 | 50 |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | DNN | 1997-10-01 | 47 |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | CIJ | 1995-12-11 | 255 |
| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | LFR | 1995-09-06 | 142 |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | CEK | 1995-06-14 | 152 |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | CEK | 1995-05-15 | 123 |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | CEO | 1994-12-07 | 36 |
| K945368 | PHOSPHORUS TEST (PHOS) | CEO | 1994-12-02 | 43 |
52 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2011-04-04.
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 Emd Chemicals, Inc.?
FDA lists 62 510(k) clearances under the applicant name “Emd Chemicals, Inc.” (first 1982, latest 2004), across 35 product codes in 6 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 Emd Chemicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emd Chemicals, Inc. is 30 days.
Which FDA product codes appear under Emd Chemicals, Inc.?
The most frequent FDA product codes under this applicant name are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 5); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 4); JIS (Calibrator, Primary, 4).
Next steps
- See all 62 Emd Chemicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Emd Chemicals, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.