S-TEST C-REACTIVE PROTEIN (CRP)— 510(k) K083040
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K083040 for S-TEST C-REACTIVE PROTEIN (CRP), Substantially Equivalent on 2009-01-30. Applicant: Alfa Wassermann Diagnostic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
Recent devices under product code DCN
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