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510(k) K832427

EASYTOUCH TROMBOPLASTIN REAGENT by Worthington Diagnostic Systems — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
July 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by Worthington Diagnostic Systems

  • K833708 — COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (January 4, 1984)
  • K832748 — COMPUR* EASYTOUCH TOTAL BILIRUBIN (October 14, 1983)
  • K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT (October 14, 1983)
  • K832749 — EASYTOUCH BUN REAGENT SET (October 14, 1983)
  • K832750 — EASYTOUCH HEMOGLOBIN REAGENT (September 26, 1983)
  • K832426 — EASYTOUCH TRIGLYCERIDES REAGENT SET (September 12, 1983)
  • K831477 — DEMAND ANALYZER SYSTEM (June 17, 1983)
  • K831318 — COMPUR* M1100 HEMATRCRIT SYSTEM (June 8, 1983)
  • K831227 — COMPUR EASY TOUCH CHEMISTRY ANALYZER- (June 2, 1983)
  • K831103 — TIA-IGM REAGENT & CALIBRATOR SETS (April 27, 1983)

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