510(k) K870176 ยท LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
| Applicant | Genetic Systems Corp., Seattle WA, US |
| Decision | Substantially Equivalent, Jul 16, 1987 |
| Received | Jan 15, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2005 | Bio Rad Laboratories, Inc. Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics G Terminated |
NOM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.