Synermed, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Synermed, Inc.” (first 1990, latest 1997), across 30 product codes in 1 review panel. Median 510(k) review time under this name: 50 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 | 7 | 7 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 3 |
| JGS | Electrode, Ion Specific, Sodium | 3 | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 2 | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
Plus 20 more product codes.
Review panels
- Clinical Chemistry (45)
Most recent Synermed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | CIG | 1997-09-25 | 37 |
| K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | CIG | 1997-08-07 | 17 |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | JJF | 1997-06-26 | 63 |
| K962479 | SYNERMED ISE REAGENTS | CGZ | 1997-03-03 | 250 |
| K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | CIG | 1996-12-18 | 78 |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | KHS | 1996-03-11 | 13 |
| K953395 | SYNERMED CALCIUM REAGENT KIT | CJY | 1995-08-31 | 44 |
| K952179 | SYNERMED ISE REAGENTS | JGS | 1995-06-20 | 42 |
| K943924 | CREATININE-PO REAGENT KIT | CGX | 1994-09-20 | 39 |
| K941091 | SYNERMED AMYLASE REAGENT KIT | JFJ | 1994-05-03 | 56 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Synermed, 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.
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.
- Synermed Intl., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synermed, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Synermed, Inc.” (first 1990, latest 1997), across 30 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Synermed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synermed, Inc. is 50 days.
Which FDA product codes appear under Synermed, Inc.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 7); CGX (Alkaline Picrate, Colorimetry, Creatinine, 3); JGS (Electrode, Ion Specific, Sodium, 3).
Next steps
- See all 45 Synermed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Synermed, 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.