Company ยท US
Wampole Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1997. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| LSR | Reagent, Borrelia Serological Reagent | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DMR | Solution, M-Nitrophenol, Specific Reagent For Cholinesterase | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LQO | Dna-Reagents, Campylobacter Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 1997 | K965131 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM Wampole Laboratories | LSR |
| Mar 26, 1997 | K965129 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM Wampole Laboratories | LSR |
| Aug 30, 1991 | K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM Wampole Laboratories | LFX |
| Oct 31, 1988 | K882896 | ONE-STEP HCG Wampole Laboratories | DHA |
| Aug 4, 1988 | K883004 | MONO-PLUS(TM) Wampole Laboratories | KTN |
| Mar 1, 1988 | K875101 | VIROGEN CMV ANTIBODY TEST Wampole Laboratories | LQO |
| Feb 17, 1988 | K875161 | MAT (TM) MICROALBUMIN TEST Wampole Laboratories | DCF |
| Jul 30, 1979 | K791309 | UCG-LYPHOTEST Wampole Laboratories | JHJ |
| Jun 28, 1979 | K790986 | RF CONTROLS Wampole Laboratories | DMR |
| Dec 29, 1978 | K781794 | BETA-TEC Wampole Laboratories | JHI |
| Nov 12, 1976 | K760336 | BIOCEPT-G Wampole Laboratories | JHI |
| Oct 21, 1976 | K760681 | INDIRECT FLUORESCENT (IFA-ANA) Wampole Laboratories | DHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||