510(k) K011166 ยท KLS Enzyme Immunoassay, Theophylline
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 10, 2001 |
| Received | Apr 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011166
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.