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510(k) K051714

TOTAL BILE ACIDS ASSAY, MODEL DZ042A by Diazyme Laboratories — Product Code KWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2005
Date Received
June 27, 2005
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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Other clearances for product code KWW

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • 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)