MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
FDA 510(k) clearance K001891 · decided 2000-07-12
Clearance details
- K-number
- K001891
- Device name
- MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
- Applicant
- Bio/Data Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-21
- Decision date
- 2000-07-12
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- GKP
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Horsham, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.