S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
FDA 510(k) clearance K072141 · decided 2008-06-24
Clearance details
- K-number
- K072141
- Device name
- S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-02
- Decision date
- 2008-06-24
- Days to decision
- 327 days
- Clearance type
- Traditional
- Product code
- CEO
- Device class
- 1
- Regulation number
- 862.1580
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Caldwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.