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510(k) K803296

ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT by Immunotech Corp. — Product Code KWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1981
Date Received
December 30, 1980
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

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  • 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)
  • K781337 — CONJUGATED BILE ACIDS RIA KIT (August 11, 1978)