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510(k) K833708

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE by Worthington Diagnostic Systems — Product Code LKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1984
Date Received
October 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Red-Cell Count By Photometry
Device Class
Class II
Regulation Number
864.7100
Review Panel
HE
Submission Type

Other clearances by Worthington Diagnostic Systems

  • K832427 — EASYTOUCH TROMBOPLASTIN REAGENT (October 14, 1983)
  • K832748 — COMPUR* EASYTOUCH TOTAL BILIRUBIN (October 14, 1983)
  • K832749 — EASYTOUCH BUN REAGENT SET (October 14, 1983)
  • K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT (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)

Other clearances for product code LKZ

  • K832771 — ERYTHROCYTE TEST (October 28, 1983)