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510(k) K962489

CHROMOLIZE TPA ASSAY KIT by Medical Diagnostic Technologies, Inc. — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
June 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
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)
  • 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)
  • K952746 — ALKALINE PHOSPHATASE REAGENT SYSTEM (November 27, 1995)

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  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)