510(k) K885044 ยท KLS Enzyme Immunoassay, Theophylline
BEHRING POLAROID OPUS THEOPHYLLINE
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Dec 29, 1988 |
| Received | Dec 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885044
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.