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510(k) K872296

BILE ACIDS REAGENT by Sigma Diagnostics, Inc. — Product Code KWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1987
Date Received
June 16, 1987
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

Other clearances by Sigma Diagnostics, Inc.

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  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

Other clearances for product code KWW

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K051714 — TOTAL BILE ACIDS ASSAY, MODEL DZ042A (December 7, 2005)
  • K970120 — BILE ACIDS REAGENT SET (March 24, 1997)
  • K803296 — ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (January 16, 1981)
  • K781337 — CONJUGATED BILE ACIDS RIA KIT (August 11, 1978)