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510(k) K910286

PLATELET AGGREGATION REAGENTS by Medical Diagnostic Technologies, Inc. — Product Code GHR

K910286 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "PLATELET AGGREGATION REAGENTS". The FDA issued a decision of Substantially Equivalent on March 19, 1991. The device falls under product code GHR (Reagent, Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Medical Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1991
Date Received
January 22, 1991
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

Other clearances by Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (September 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (August 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (November 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • 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)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367 (May 20, 1991)
  • K910800 — ADP REAGENT (May 20, 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)

FDA data resources