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510(k) K781337

CONJUGATED BILE ACIDS RIA KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1978
Date Received
August 3, 1978
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 Bd Becton Dickinson Vacutainer Systems Preanalytic

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  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

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)
  • K872296 — BILE ACIDS REAGENT (August 26, 1987)
  • K803296 — ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (January 16, 1981)