510(k) K911590 ยท LSR Reagent, Borrelia Serological Reagent
IMMUNOWELL BORRELIA (LYME)TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 20, 1991 |
| Received | Apr 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2013 | Innominata Dba Genbio ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manuf Terminated |
LSR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.