510(k) K971522 ยท GTZ Antisera, All Groups, Streptococcus Spp.
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Mar 3, 1998 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA Terminated |
GTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.