Wampole Laboratories: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Wampole Laboratories” (first 1976, latest 1997), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 74 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 | 2 | 2 |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DMR | Solution, M-Nitrophenol, Specific Reagent For Cholinesterase | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
| LQO | Dna-Reagents, Campylobacter Spp. | 1 | 1 |
Review panels
- Microbiology (5)
- Clinical Chemistry (4)
- Immunology (2)
- Clinical Toxicology (1)
Most recent Wampole Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965131 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | 1997-03-26 | 93 |
| K965129 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | LSR | 1997-03-26 | 93 |
| K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM | LFX | 1991-08-30 | 151 |
| K882896 | ONE-STEP HCG | DHA | 1988-10-31 | 112 |
| K883004 | MONO-PLUS(TM) | KTN | 1988-08-04 | 17 |
| K875101 | VIROGEN CMV ANTIBODY TEST | LQO | 1988-03-01 | 82 |
| K875161 | MAT (TM) MICROALBUMIN TEST | DCF | 1988-02-17 | 64 |
| K791309 | UCG-LYPHOTEST | JHJ | 1979-07-30 | 14 |
| K790986 | RF CONTROLS | DMR | 1979-06-28 | 34 |
| K781794 | BETA-TEC | JHI | 1978-12-29 | 65 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wampole Laboratories.
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 Wampole Laboratories?
FDA lists 12 510(k) clearances under the applicant name “Wampole Laboratories” (first 1976, latest 1997), across 10 product codes in 4 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 Wampole Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wampole Laboratories is 74 days.
Which FDA product codes appear under Wampole Laboratories?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); LSR (Reagent, Borrelia Serological Reagent, 2); DCF (Albumin, Antigen, Antiserum, Control, 1).
Next steps
- See all 12 Wampole Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JHI, Wampole Laboratories'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.