510(k) K071706 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
| Applicant | Clinical Data, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 20, 2007 |
| Received | Jun 21, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071706
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.