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510(k) K943153

MICROSAMPLE COAGULATION ANALYZER by Bio/Data Corp. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
June 30, 1994
Clearance Type
Traditional
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

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  • K853246 — CALCIUM CHLORIDE (August 13, 1985)
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