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510(k) K912774

ARACHIDONIC ACID by Helena Laboratories — Product Code JBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1991
Date Received
June 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aggregrometer, Platelet
Device Class
Class II
Regulation Number
864.6675
Review Panel
HE
Submission Type

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Other clearances for product code JBX

  • K932566 — AGGRO/LINK CONTROL SOFTWARE (November 2, 1993)
  • K881829 — PAT PLATELET AGGREGATION TEST (July 1, 1988)
  • K862775 — ASSERACHROM B-TG KIT (October 22, 1986)
  • K851025 — AGGRO/LINK COMPUTER INTERFACE (June 12, 1985)
  • K850592 — PLATELET AGGREGATION REAGENT (May 13, 1985)
  • K832929 — RISTOCETIN PLATELET AGGREGA-REAGENT TEST (September 29, 1983)
  • K830749 — PLATELET AGGREGOMETER (May 16, 1983)
  • K821005 — PLATELET AGGREGATION PROFILER #PAP-4 (June 1, 1982)
  • K811290 — ARACHIDONIC ACID (July 27, 1981)
  • K781710 — BUFFER, COLLAGEN REAGENT AND DILUENT (October 24, 1978)