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510(k) K851153

COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE by Astral Medical Systems — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1985
Date Received
March 22, 1985
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

Other clearances by Astral Medical Systems

  • K900506 — MODIFIED COATRON II AND COATRON JR. (March 12, 1990)
  • K853734 — APOLLO DENSITOMETER (September 25, 1985)
  • K851154 — ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (May 13, 1985)

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