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510(k) K832428

PLATELET AGGREGATION REAGENT SET by Helena Laboratories — Product Code GHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1983
Date Received
July 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

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Other clearances for product code GHR

  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K952252 — ADP REAGENT, MODIFIED (September 8, 1995)
  • K922800 — PLATELET AGGREGATION REAGENTS (August 26, 1992)
  • K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367 (May 20, 1991)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910800 — ADP REAGENT (May 20, 1991)
  • K910286 — PLATELET AGGREGATION REAGENTS (March 19, 1991)
  • K900792 — RISTOCETIN (March 27, 1990)
  • K820422 — PLATELET AGGREGOMETERS (March 16, 1982)
  • K760198 — KIT, PLATELET AGGREGATION REAGENT (#390) (July 19, 1976)