Wampole Laboratories
Medical device manufacturer in Cranbury, NJ.
12510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- LSR Reagent, Borrelia Serological Reagent 2
- DHN Antinuclear Antibody, Indirect… 1
- DMR Solution, M-Nitrophenol, Specific Reagent… 1
- JHJ Agglutination Method, Human Chorionic… 1
- DCF Albumin, Antigen, Antiserum, Control 1
- LQO Dna-Reagents, Campylobacter Spp. 1
- KTN System, Test, Infectious Mononucleosis 1
- DHA System, Test, Human Chorionic Gonadotropin 1
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K965129 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K911444 | Rubella Virus Immunological Test SystemLFX · Traditional | 08/30/1991SE |
| K882896 | One-Step HCGDHA · Traditional | 10/31/1988SE |
| K883004 | Mono-Plus(Tm)KTN · Traditional | 08/04/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | 03/01/1988SE |
| K875161 | Mat (TM) Microalbumin TestDCF · Traditional | 02/17/1988SE |
| K791309 | Ucg-LyphotestJHJ · Traditional | 07/30/1979SE |
| K790986 | RF ControlsDMR · Traditional | 06/28/1979SE |
| K781794 | Beta-TecJHI · Traditional | 12/29/1978SE |
| K760336 | Biocept-GJHI · Traditional | 11/12/1976SE |
| K760681 | Indirect Fluorescent (Ifa-Ana)DHN · Traditional | 10/21/1976SE |