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510(k) K832929

RISTOCETIN PLATELET AGGREGA-REAGENT TEST by Sigma Chemical Co. — Product Code JBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 24, 1983
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)
  • K912774 — ARACHIDONIC ACID (August 22, 1991)
  • 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)
  • 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)