510(k) K001891
K001891 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C". The FDA issued a decision of Substantially Equivalent on July 12, 2000. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Bio/Data Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2000
- Date Received
- June 21, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Coagulation, Automated
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type