MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
FDA 510(k) clearance K070734 · decided 2007-04-09
Clearance details
- K-number
- K070734
- Device name
- MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2007-03-16
- Decision date
- 2007-04-09
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. H recall (Z-0482-2009) | Alfa Wassermann, Inc. | 2008-12-17 |