S-TEST CA
FDA 510(k) clearance K072356 · decided 2008-06-24
Clearance details
- K-number
- K072356
- Device name
- S-TEST CA
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-22
- Decision date
- 2008-06-24
- Days to decision
- 307 days
- Clearance type
- Traditional
- Product code
- CJY
- Device class
- 2
- Regulation number
- 862.1145
- 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.