Submission Details
| 510(k) Number | K001891 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 21, 2000 |
| Decision Date | July 12, 2000 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Special
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
Jul 2000
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K001891 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Bio/Data Corp. (Horsham, US). The FDA issued a Cleared decision on July 12, 2000, 21 days after receiving the submission on June 21, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.
Device Classification
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5400 |
Manufacturer
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