S40 CLINICAL ANALYZER, S TEST IP, S TEST UA— 510(k) K072141
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K072141 for S40 CLINICAL ANALYZER, S TEST IP, S TEST UA, Substantially Equivalent on 2008-06-24. Applicant: Alfa Wassermann Diagnostic Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Product code
- Code CEO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1580
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
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