ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
FDA 510(k) clearance K952337 · decided 1996-02-09
Clearance details
- K-number
- K952337
- Device name
- ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-19
- Decision date
- 1996-02-09
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. recall (Z-0650-05) | Roche Diagnostics Corp. | 2005-03-23 |
| Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322. recall (Z-0651-05) | Roche Diagnostics Corp. | 2005-03-23 |