S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022— 510(k) K091333
Substantially EquivalentAlfa Wassermann, Inc.
FDA 510(k) clearance K091333 for S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022, Substantially Equivalent on 2009-08-03. Applicant: Alfa Wassermann, Inc.. Device class: 1.
Clearance details
- Applicant
- Alfa Wassermann, Inc.
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
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