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510(k) K852484

PLASTINEX by Bio/Data Corp. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
June 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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  • K873382 — PLATELET EXTRACT REAGENT (November 20, 1987)
  • 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)

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