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510(k) K891179

EDL NORMAL COAGULATION CONTROL by Elite Diagnostic , Ltd. — Product Code GIZ

K891179 is an FDA 510(k) premarket notification submitted by Elite Diagnostic , Ltd. for the device "EDL NORMAL COAGULATION CONTROL". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code GIZ (Plasma, Control, Normal), a Class II device regulated under 21 CFR 864.5425. Elite Diagnostic , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1989
Date Received
March 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Control, Normal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Elite Diagnostic , Ltd.

  • K891370 — EDL ONE-STAGE PROTHROMBIN TIME REAGENT (April 21, 1989)
  • K890859 — EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (April 21, 1989)
  • K891175 — EDL ABNORMAL COAGULATION CONTROL (April 10, 1989)
  • K890619 — EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (March 15, 1989)

Other clearances for product code GIZ

  • K060968 — STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; (May 15, 2007)
  • K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (December 2, 2004)
  • K023309 — CONTROL PLASMA N (November 1, 2002)
  • K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10 (December 10, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)
  • K001256 — CONTROL PLASMA N (May 24, 2000)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089) (October 31, 1997)
  • K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (August 13, 1996)
  • K941737 — SPECIALTY ASSAYED CONTROL-1 (October 7, 1994)

FDA data resources