Syva Co., Dade Behring, Inc.: FDA clearances and approvals
Syva Co., Dade Behring, Inc. has 19 FDA 510(k) clearances (first 2000, latest 2001), across 19 product codes in 2 review panels. Median 510(k) review time: 24 days.
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 |
|---|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
Plus 9 more product codes.
Review panels
Most recent Syva Co., Dade Behring, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | KXT | 2001-07-02 | 12 |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | LAN | 2001-06-18 | 24 |
| K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | LBZ | 2001-06-12 | 19 |
| K011300 | EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 | LDJ | 2001-05-17 | 17 |
| K011306 | EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 | JXM | 2001-05-16 | 16 |
| K011289 | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 | DJG | 2001-05-15 | 18 |
| K011161 | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 | LCM | 2001-05-15 | 29 |
| K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 | KLS | 2001-05-10 | 24 |
| K011164 | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 | KXS | 2001-05-10 | 24 |
| K011163 | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 | JXN | 2001-05-10 | 24 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syva Co., Dade Behring, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Syva Co., Dade Behring, Inc. have?
Syva Co., Dade Behring, Inc. has 19 FDA 510(k) clearances (first 2000, latest 2001), across 19 product codes in 2 review panels.
How long does FDA take to clear Syva Co., Dade Behring, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Syva Co., Dade Behring, Inc.'s cleared 510(k)s is 24 days.
What devices does Syva Co., Dade Behring, Inc. make?
Its most frequent FDA product codes are DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, 1); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DIS (Enzyme Immunoassay, Barbiturate, 1).
Has Syva Co., Dade Behring, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Syva Co., Dade Behring, Inc. Related entities may recall under other names.
Next steps
- See all 19 Syva Co., Dade Behring, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIC, Syva Co., Dade Behring, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.