ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)— 510(k) K071706
Substantially EquivalentClinical Data, Inc.
FDA 510(k) clearance K071706 for ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118), Substantially Equivalent on 2007-12-20. Applicant: Clinical Data, Inc.. Device class: 1.
Clearance details
- Applicant
- Clinical Data, Inc.
- Product code
- Code LBS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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