510(k) K900373 ยท KLS Enzyme Immunoassay, Theophylline
BIOTRACK THEOPHYLLINE TEST CARTRIDGE
| Applicant | Biotrack, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, May 30, 1990 |
| Received | Jan 26, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900373
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.