510(k) K092704 ยท LSK Dna-Reagents, Chlamydia
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, May 28, 2010 |
| Received | Sep 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2011 | Abbott Molecular Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for t Terminated |
LSK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.