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510(k) K842286

DIA T1, T2 & T3 by Diatech, Inc. — Product Code JPK

K842286 is an FDA 510(k) premarket notification submitted by Diatech, Inc. for the device "DIA T1, T2 & T3". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Diatech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
June 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
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)
  • 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)
  • K840802 — DIA THROMBIN DIA PLASTIN (May 1, 1984)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources