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510(k) K955300

TOTAL BILIRUBIN PROCEDURE by Data Medical Associates, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1995
Date Received
November 20, 1995
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 Data Medical Associates, Inc.

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  • K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (July 1, 1996)
  • K955302 — SERUM BICARBONATE/CARBON DIOXIDE (February 29, 1996)
  • K955796 — IRON CALIBRATOR & CALIBRATION VERIFICATION SET (February 29, 1996)
  • K952437 — DMA GLUCOSE HEXOKINASE U.V. PROCEDURE (October 3, 1995)
  • K946161 — DMA TOTAL CHOLESTEROL PROCEDURE (August 23, 1995)
  • K946354 — DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (May 8, 1995)
  • K946355 — DMA ALBUMIN PROCEDURE (March 1, 1995)
  • K944255 — DMA CALCIUM PLUS PROCEDURE (December 6, 1994)

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  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
  • K150510 — Total Bilirubin (April 2, 2015)
  • K131544 — COBAS C BILIRUBIN TOTAL GEN.3 (July 17, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (June 7, 2013)
  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)