ABX MICROS 60 HEMATOLOGY ANALYZER
FDA 510(k) clearance K014203 · decided 2002-02-28
Clearance details
- K-number
- K014203
- Device name
- ABX MICROS 60 HEMATOLOGY ANALYZER
- Applicant
- Abx Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2001-12-21
- Decision date
- 2002-02-28
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- GKX
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CLEAR POROUS PLASTIC-HYPOALLERGENIC (K840948) | Gainor Medical | 1984-08-14 |
Recalls involving this device
No recalls on record reference this clearance.