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510(k) K012668

RAICHEM GLUCOSE UV REAGENT by Hemagen Diagnostics, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2001
Date Received
August 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Hemagen Diagnostics, Inc.

  • K041052 — RAICHEM GLUCOSE UV (LIQUID) (June 30, 2004)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (June 16, 2003)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (September 17, 2002)
  • K022767 — RAICHEM LIPID CALIBRATOR (September 3, 2002)
  • K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (July 29, 2002)
  • K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT (July 19, 2002)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)

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