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510(k) K860342

MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP by Bio/Data Corp. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
January 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K852484 — PLASTINEX (August 12, 1985)

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