510(k) K810863 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
KALLESTAD HEP-2 CELL LINE SUBSTRATE
| Applicant | Kallestad Laboratories, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 14, 1981 |
| Received | Mar 31, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810863
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Bio-Rad Laboratories Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, Terminated |
DBM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.