510(k) K053157 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
| Applicant | Dade Behring, Inc., Newark, DE, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | Nov 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053157
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.