510(k) K855227 ยท KLS Enzyme Immunoassay, Theophylline
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
| Applicant | Bioclinical Systems, Inc., St.Louis MO, US |
| Decision | Substantially Equivalent, Apr 11, 1986 |
| Received | Dec 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855227
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.