Ampcor, Inc.
Bridgeport, NJ, US
Ampcor, Inc. appears in FDA device records in Bridgeport, NJ. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Ampcor, Inc. between 1988 and 1992. The busiest year on record is 1988, with 7. The most recent is 1992, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 7 |
| 1989 | 5 |
| 1991 | 1 |
| 1992 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | KTN | Substantially Equivalent | |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | KTN | Substantially Equivalent | |
| K910438 | DIPSTICK SALMONELLA | GRM | Substantially Equivalent | |
| K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST | DHA | Substantially Equivalent | |
| K890048 | QUIK-DOT TOXOPLASMOSIS | LLA | Substantially Equivalent | |
| K892146 | C REACTIVE PROTEIN LIQUID | DCK | Substantially Equivalent | |
| K892119 | QUIK-DOT C REACTIVE PROTEIN | DCK | Substantially Equivalent | |
| K890025 | QUIK-DOT ANTISTREPTOLYSIN-O | GTQ | Substantially Equivalent | |
| K884750 | GROUP A STREP, BETA-STREP | GTZ | Substantially Equivalent | |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | JHJ | Substantially Equivalent | |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | JHJ | Substantially Equivalent | |
| K880477 | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | GMQ | Substantially Equivalent | |
| K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | GMQ | Substantially Equivalent | |
| K880164 | RF CARD TEST & RF LIQUID TEST | DHR | Substantially Equivalent | |
| K880148 | INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST | KTN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GMQAntigens, Nontreponemal, All
- GRMAntisera, All Groups, Salmonella Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- LLADirect Agglutination Test, Toxoplasma Gondii
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain