510(k) K853372 ยท KLS Enzyme Immunoassay, Theophylline
GEMSTAR IPA THEOPHYLLINE TEST KIT
| Applicant | Electro-Nucleonics Laboratories, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Sep 4, 1985 |
| Received | Aug 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853372
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.