510(k) K871484 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Belleville NJ, US |
| Decision | Substantially Equivalent, May 28, 1987 |
| Received | Apr 15, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871484
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.