GLUCOSE TEST SYSTEM
FDA 510(k) clearance K113137 · decided 2012-01-06
Clearance details
- K-number
- K113137
- Device name
- GLUCOSE TEST SYSTEM
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-10-24
- Decision date
- 2012-01-06
- Days to decision
- 74 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to recall (Z-1386-2012) | Roche Diagnostics Operations, Inc. | 2012-04-09 |
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|---|---|---|
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| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
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| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |