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510(k) K061991

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA by Helena Laboratories — Product Code GHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2007
Date Received
July 13, 2006
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

  • K952252 — ADP REAGENT, MODIFIED (September 8, 1995)
  • K922800 — PLATELET AGGREGATION REAGENTS (August 26, 1992)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910800 — ADP REAGENT (May 20, 1991)
  • K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367 (May 20, 1991)
  • K910286 — PLATELET AGGREGATION REAGENTS (March 19, 1991)
  • K900792 — RISTOCETIN (March 27, 1990)
  • K832428 — PLATELET AGGREGATION REAGENT SET (October 20, 1983)
  • K820422 — PLATELET AGGREGOMETERS (March 16, 1982)
  • K760198 — KIT, PLATELET AGGREGATION REAGENT (#390) (July 19, 1976)