ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
FDA 510(k) clearance K123953 · decided 2013-05-02
Clearance details
- K-number
- K123953
- Device name
- ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-21
- Decision date
- 2013-05-02
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- KHS
- Device class
- 2
- Regulation number
- 862.1160
- 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.