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510(k) K841461

COAGULATION CONTROL PLASMA LEVEL 1/2/3 by Diatech, Inc. — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 9, 1984
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 Diatech, Inc.

  • K881685 — FIBRINOGENTEST-O (August 9, 1988)
  • K854938 — COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. (March 12, 1986)
  • K854089 — DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT (January 6, 1986)
  • K854090 — DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT (January 6, 1986)
  • K842286 — DIA T1, T2 & T3 (September 11, 1984)
  • K841523 — OWREN'S VERONAL BUFFERR (June 1, 1984)
  • K841366 — DIA FIBRIN (June 1, 1984)
  • K841462 — HEPARIN COAGULATION CONTROL PLASMA 1- (June 1, 1984)
  • K841365 — DIA REPTIN (June 1, 1984)
  • K840802 — DIA THROMBIN DIA PLASTIN (May 1, 1984)

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  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • 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)