510(k) K792610 ยท DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
| Applicant | Kallestad Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 22, 1980 |
| Received | Dec 18, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K792610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Bio-Rad Laboratories Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Terminated |
DBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.