ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
FDA 510(k) clearance K103615 · decided 2011-09-08
Clearance details
- K-number
- K103615
- Device name
- ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-09
- Decision date
- 2011-09-08
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- CDN
- Device class
- 2
- Regulation number
- 862.1770
- 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
| Record | Firm | Date |
|---|---|---|
| Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technolo recall (Z-0743-2013) | Alfa Wassermann, Inc. | 2013-01-28 |