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510(k) K854089

DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT by Diatech, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1986
Date Received
October 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
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)
  • K842286 — DIA T1, T2 & T3 (September 11, 1984)
  • K841365 — DIA REPTIN (June 1, 1984)
  • K841523 — OWREN'S VERONAL BUFFERR (June 1, 1984)
  • K841366 — DIA FIBRIN (June 1, 1984)
  • K841462 — HEPARIN COAGULATION CONTROL PLASMA 1- (June 1, 1984)
  • K841461 — COAGULATION CONTROL PLASMA LEVEL 1/2/3 (May 2, 1984)
  • K840802 — DIA THROMBIN DIA PLASTIN (May 1, 1984)

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