ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
FDA 510(k) clearance K113438 · decided 2012-06-01
Clearance details
- K-number
- K113438
- Device name
- ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-21
- Decision date
- 2012-06-01
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- JMO
- Device class
- 1
- Regulation number
- 862.1415
- 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.