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510(k) K911866

TRACE TOTAL/DIRECT BILIRUBIN REAGENT by Trace Scientific , Ltd. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
April 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

Other clearances by Trace Scientific , Ltd.

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  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K903897 — TRIGLYCERIDES REAGENT GPO 5 X CONC. (October 1, 1990)

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