S-TEST CREATININE (CRE)— 510(k) K080073
Substantially EquivalentAlfa Wassermann, Inc.
FDA 510(k) clearance K080073 for S-TEST CREATININE (CRE), Substantially Equivalent on 2008-06-30. Applicant: Alfa Wassermann, Inc.. Device class: 2.
Clearance details
- Applicant
- Alfa Wassermann, Inc.
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
Recent devices under product code JFY
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