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510(k) K900792

RISTOCETIN by Medical Diagnostic Technologies, Inc. — Product Code GHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1990
Date Received
February 20, 1990
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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  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)

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)
  • K910800 — ADP REAGENT (May 20, 1991)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910286 — PLATELET AGGREGATION REAGENTS (March 19, 1991)
  • K832428 — PLATELET AGGREGATION REAGENT SET (October 20, 1983)
  • K820422 — PLATELET AGGREGOMETERS (March 16, 1982)
  • K760198 — KIT, PLATELET AGGREGATION REAGENT (#390) (July 19, 1976)