Wyntek Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Wyntek Diagnostics, Inc.” (first 1995, latest 2000), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 3 | 3 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
Review panels
- Clinical Chemistry (9)
- Microbiology (3)
Most recent Wyntek Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992658 | OSOM ULTRA STREP A TEST, MODEL 147 | GTY | 2000-01-18 | 162 |
| K990578 | OSOM CARD II HCG-URINE TEST, MODEL 102 | JHI | 1999-03-09 | 14 |
| K990576 | OSOM CARD PREGNANCY TEST, MODEL 103 | LCX | 1999-03-09 | 14 |
| K974159 | OSOM HCG-URINE TEST MODEL 101 | JHI | 1997-12-24 | 71 |
| K973879 | OSOM CARD HCG-URINE TEST | JHI | 1997-11-04 | 55 |
| K972231 | OSOM MONO TEST 143 | KTN | 1997-08-26 | 71 |
| K965227 | OSOM CLASSIC HCG-URINE TEST (115) | JHI | 1997-02-04 | 36 |
| K965184 | PERFECTA PREGNANCY TEST | LCX | 1997-02-04 | 42 |
| K961423 | OSOM STREP A TEST | GTZ | 1996-10-11 | 182 |
| K955141 | OSOM HCG COMBO TEST | JJX | 1995-12-06 | 23 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wyntek Diagnostics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wyntek Diagnostics, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Wyntek Diagnostics, Inc.” (first 1995, latest 2000), across 6 product codes in 2 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 Wyntek Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wyntek Diagnostics, Inc. is 45 days.
Which FDA product codes appear under Wyntek Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 5); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 3); GTY (Antigens, All Groups, Streptococcus Spp., 1).
Next steps
- See all 12 Wyntek Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Wyntek Diagnostics, 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.