OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
FDA 510(k) clearance K031380 · decided 2003-11-14
Clearance details
- K-number
- K031380
- Device name
- OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-01
- Decision date
- 2003-11-14
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177 recall (Z-2170-2011) | Beckman Coulter Inc. | 2011-05-10 |