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510(k) K892905

DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. by Catachem, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1989
Date Received
April 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

Other clearances by Catachem, Inc.

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K903341 — MAGNESIUM (August 22, 1990)
  • K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (July 31, 1990)
  • K902877 — TOTAL IRON FOR MANUAL/AUTOMATED (July 27, 1990)
  • K895748 — BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (December 21, 1989)
  • K895821 — URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (December 5, 1989)
  • K894715 — CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (November 8, 1989)
  • K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (October 12, 1989)

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  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
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