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510(k) K840928

FACTOR DEFICIENT SUBSTRATE PLASMA VIII by Diatech, Inc. — Product Code GGP

K840928 is an FDA 510(k) premarket notification submitted by Diatech, Inc. for the device "FACTOR DEFICIENT SUBSTRATE PLASMA VIII". The FDA issued a decision of Substantially Equivalent on April 30, 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
April 30, 1984
Date Received
March 2, 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)
  • K841462 — HEPARIN COAGULATION CONTROL PLASMA 1- (June 1, 1984)
  • K841523 — OWREN'S VERONAL BUFFERR (June 1, 1984)
  • K841366 — DIA FIBRIN (June 1, 1984)
  • K841365 — DIA REPTIN (June 1, 1984)
  • K841461 — COAGULATION CONTROL PLASMA LEVEL 1/2/3 (May 2, 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