Syva Co.: FDA filings under this applicant name
FDA lists 448 510(k) clearances under the applicant name “Syva Co.” (first 1976, latest 2001), across 110 product codes in 8 review panels. Median 510(k) review time under this name: 35 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | 22 | 22 |
| DKB | Calibrators, Drug Mixture | 21 | 21 |
| DLJ | Calibrators, Drug Specific | 18 | 18 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 17 | 17 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 14 | 14 |
| DIF | Drug Mixture Control Materials | 13 | 13 |
| DIS | Enzyme Immunoassay, Barbiturate | 13 | 13 |
| DKZ | Enzyme Immunoassay, Amphetamine | 13 | 13 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 13 | 13 |
| KLT | Enzyme Immunoassay, Carbamazepine | 12 | 12 |
Plus 100 more product codes.
Review panels
- Clinical Toxicology (335)
- Clinical Chemistry (67)
- Microbiology (27)
- Immunology (9)
- Hematology (3)
- Anesthesiology (2)
- Cardiovascular (1)
- General and Plastic Surgery (1)
Most recent Syva Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | DKJ | 2001-08-13 | 59 |
| K012257 | EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 | DKZ | 2001-08-03 | 16 |
| K011947 | EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL | LEG | 2001-07-02 | 11 |
| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | DLZ | 2001-06-06 | 20 |
| K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | DIP | 2001-05-17 | 15 |
| K993981 | SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL | JXN | 2000-02-01 | 69 |
| K993980 | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | DML | 2000-02-01 | 69 |
| K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | DIO | 2000-01-27 | 64 |
| K993987 | SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL | KLT | 2000-01-27 | 64 |
| K993986 | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | KXS | 2000-01-27 | 64 |
438 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syva Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Syva Co., Dade Behring, Inc. (19 510(k)s)
- Syva / A Syntex Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syva Co.?
FDA lists 448 510(k) clearances under the applicant name “Syva Co.” (first 1976, latest 2001), across 110 product codes in 8 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 Syva Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syva Co. is 35 days.
Which FDA product codes appear under Syva Co.?
The most frequent FDA product codes under this applicant name are LAS (Drug Specific Control Materials, 22); DKB (Calibrators, Drug Mixture, 21); DLJ (Calibrators, Drug Specific, 18).
Next steps
- See all 448 Syva Co. clearances with predicates and recalls
- Run predicate analysis for product code LAS, Syva Co.'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.