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510(k) K841461

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

K841461 is an FDA 510(k) premarket notification submitted by Diatech, Inc. for the device "COAGULATION CONTROL PLASMA LEVEL 1/2/3". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Diatech, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K854090 — DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT (January 6, 1986)
  • K854089 — DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT (January 6, 1986)
  • K842286 — DIA T1, T2 & T3 (September 11, 1984)
  • K841366 — DIA FIBRIN (June 1, 1984)
  • K841523 — OWREN'S VERONAL BUFFERR (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)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • 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)

FDA data resources