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510(k) K022767

RAICHEM LIPID CALIBRATOR by Hemagen Diagnostics, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2002
Date Received
August 21, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Hemagen Diagnostics, Inc.

  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K041052 — RAICHEM GLUCOSE UV (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)
  • K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (July 29, 2002)
  • K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT (July 19, 2002)
  • K012668 — RAICHEM GLUCOSE UV REAGENT (October 15, 2001)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)

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  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
  • K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (October 12, 2012)