Seradyn, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under 2 spellings of the applicant name “Seradyn, Inc.” (first 1988, latest 2007), across 26 product codes in 5 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | 2 | 2 |
| LCD | Enzyme Immunoassay, Gentamicin | 2 | 2 |
| LEG | Enzyme Immunoassay, Valproic Acid | 2 | 2 |
| NWM | Immunoassay, Anti-Seizure Drug | 2 | 2 |
| DEF | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 | 1 |
| GSA | Antisera, All Mycoplasma Spp. | 1 | 1 |
| JFT | Fluorometric, Cortisol | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
Plus 16 more product codes.
Review panels
- Clinical Toxicology (17)
- Clinical Chemistry (8)
- Immunology (2)
- Microbiology (2)
- Hematology (1)
Most recent Seradyn, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | NWM | 2007-05-17 | 70 |
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | ORH | 2007-01-12 | 105 |
| K062204 | ARCHITECT CORTISOL ASSAY | JFT | 2006-09-22 | 52 |
| K060998 | QMS TOBRAMYCIN | LCR | 2006-07-21 | 101 |
| K060709 | MULTIGENT GENTAMICIN | LCD | 2006-06-15 | 91 |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | LBZ | 2005-12-23 | 79 |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | NWM | 2005-11-18 | 191 |
| K052815 | QMS AMIKACIN REAGENTS | KLQ | 2005-11-01 | 28 |
| K050419 | QMS VANCOMYCIN | LEH | 2005-04-01 | 42 |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | JIT | 2004-11-03 | 70 |
20 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-12-20.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Seradyn, Inc. (28)
- Seradyn (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Seradyn, Inc.?
FDA lists 30 510(k) clearances under 2 spellings of the applicant name “Seradyn, Inc.” (first 1988, latest 2007), across 26 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 Seradyn, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seradyn, Inc. is 78 days.
Which FDA product codes appear under Seradyn, Inc.?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 2); LCD (Enzyme Immunoassay, Gentamicin, 2); LEG (Enzyme Immunoassay, Valproic Acid, 2).
Next steps
- See all 30 Seradyn, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Seradyn, 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.