POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC— 510(k) K100550
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K100550 for POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC, Substantially Equivalent on 2010-09-28. Applicant: Polymedco, Inc.. Device class: 1.
Clearance details
- Applicant
- Polymedco, 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
- Cortlandt Manor, NY, US
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