Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AbbottLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Wampole Laboratories with 12 510(k) clearances. The most recent is a 510(k) clearance dated Mar 26, 1997: BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM.
| Mar 26, 1997 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMK965131 · LSR | 510(k) clearances |
| Mar 26, 1997 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMK965129 · LSR | 510(k) clearances |
| Aug 30, 1991 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEMK911444 · LFX | 510(k) clearances |
| Oct 31, 1988 | ONE-STEP HCGK882896 · DHA | 510(k) clearances |
| Aug 4, 1988 | MONO-PLUS(TM)K883004 · KTN | 510(k) clearances |
| Mar 1, 1988 | VIROGEN CMV ANTIBODY TESTK875101 · LQO | 510(k) clearances |
| Feb 17, 1988 | MAT (TM) MICROALBUMIN TESTK875161 · DCF | 510(k) clearances |
| Jul 30, 1979 | UCG-LYPHOTESTK791309 · JHJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
