510(k) K974503 ยท LSL Dna-Reagents, Neisseria
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
| Applicant | Roche Molecular Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 1, 1999 |
| Received | Nov 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2004 | Roche Molecular Systems Inc Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.)
Kit: Amplicor CT/NG NG Detection Kit Terminated |
LSL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.