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510(k) K062503

CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT by Catachem, Inc. — Product Code KWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2007
Date Received
August 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cholyglycine, Bile Acids
Device Class
Class II
Regulation Number
862.1177
Review Panel
CH
Submission Type

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  • 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)
  • K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (October 12, 1989)
  • K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (October 12, 1989)

Other clearances for product code KWW

  • K051714 — TOTAL BILE ACIDS ASSAY, MODEL DZ042A (December 7, 2005)
  • K970120 — BILE ACIDS REAGENT SET (March 24, 1997)
  • K872296 — BILE ACIDS REAGENT (August 26, 1987)
  • K803296 — ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (January 16, 1981)
  • K781337 — CONJUGATED BILE ACIDS RIA KIT (August 11, 1978)