Wampole Laboratories
Mchenry, IL, US
Wampole Laboratories appears in FDA device records in Mchenry, IL. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Wampole Laboratories between 1976 and 1997. The busiest year on record is 1988, with 4. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1978 | 1 |
| 1979 | 2 |
| 1988 | 4 |
| 1991 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K965131 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | |
| K965129 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | |
| K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM | LFX | Substantially Equivalent | |
| K882896 | ONE-STEP HCG | DHA | Substantially Equivalent | |
| K883004 | MONO-PLUS(TM) | KTN | Substantially Equivalent | |
| K875101 | VIROGEN CMV ANTIBODY TEST | LQO | Substantially Equivalent | |
| K875161 | MAT (TM) MICROALBUMIN TEST | DCF | Substantially Equivalent | |
| K791309 | UCG-LYPHOTEST | JHJ | Substantially Equivalent | |
| K790986 | RF CONTROLS | DMR | Substantially Equivalent | |
| K781794 | BETA-TEC | JHI | Substantially Equivalent | |
| K760336 | BIOCEPT-G | JHI | Substantially Equivalent | |
| K760681 | INDIRECT FLUORESCENT (IFA-ANA) | DHN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DCFAlbumin, Antigen, Antiserum, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- LQODna-Reagents, Campylobacter Spp.
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LSRReagent, Borrelia Serological Reagent
- DMRSolution, M-Nitrophenol, Specific Reagent For Cholinesterase
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- JHIVisual, Pregnancy Hcg, Prescription Use
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