510(k) K820397 ยท LER Fluorescent Immunoassay, Theophylline
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
| Applicant | American Diagnostic Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 2, 1982 |
| Received | Feb 11, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820397
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.