510(k) K033809 ยท KLR Enzyme Immunoassay, Lidocaine
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Feb 20, 2004 |
| Received | Dec 8, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033809
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.