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510(k) K001891

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C by Bio/Data Corp. — Product Code GKP

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

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  • K860751 — VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA (March 18, 1986)
  • K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (March 4, 1986)
  • K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P (January 7, 1986)
  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)
  • K852484 — PLASTINEX (August 12, 1985)

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