Ampcor, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Ampcor, Inc.” (first 1988, latest 1992), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| GMQ | Antigens, Nontreponemal, All | 2 | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GRM | Antisera, All Groups, Salmonella Spp. | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| LLA | Direct Agglutination Test, Toxoplasma Gondii | 1 | 1 |
Review panels
- Microbiology (9)
- Clinical Chemistry (3)
- Immunology (3)
Most recent Ampcor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | KTN | 1992-07-14 | 60 |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | KTN | 1992-07-14 | 60 |
| K910438 | DIPSTICK SALMONELLA | GRM | 1991-09-13 | 225 |
| K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST | DHA | 1989-08-21 | 87 |
| K890048 | QUIK-DOT TOXOPLASMOSIS | LLA | 1989-06-09 | 154 |
| K892146 | C REACTIVE PROTEIN LIQUID | DCK | 1989-04-14 | 14 |
| K892119 | QUIK-DOT C REACTIVE PROTEIN | DCK | 1989-04-14 | 14 |
| K890025 | QUIK-DOT ANTISTREPTOLYSIN-O | GTQ | 1989-01-31 | 27 |
| K884750 | GROUP A STREP, BETA-STREP | GTZ | 1988-12-22 | 38 |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | JHJ | 1988-05-17 | 125 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ampcor, 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.
- Ampcor Diagnostics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ampcor, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Ampcor, Inc.” (first 1988, latest 1992), across 10 product codes in 3 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 Ampcor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ampcor, Inc. is 60 days.
Which FDA product codes appear under Ampcor, Inc.?
The most frequent FDA product codes under this applicant name are KTN (System, Test, Infectious Mononucleosis, 3); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 2); GMQ (Antigens, Nontreponemal, All, 2).
Next steps
- See all 15 Ampcor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KTN, Ampcor, 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.