G5 I HBA1C TEST, G5 II HBA1C TEST
FDA 510(k) clearance K041635 · decided 2004-08-16
Clearance details
- K-number
- K041635
- Device name
- G5 I HBA1C TEST, G5 II HBA1C TEST
- Applicant
- Provalis Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-16
- Decision date
- 2004-08-16
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridg recall (Z-0122-2011) | Bio-Rad Laboratories Inc | 2010-10-22 |
| in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Cat recall (Z-0109-2011) | Bio-Rad Laboratories Inc | 2010-10-21 |
| Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic t recall (Z-2460-2008) | Cholestech Corp | 2008-09-23 |
| Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test recall (Z-0171-06) | Provalis Diagnostics | 2005-11-18 |