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510(k) K955940

TOTAL BILIRUBIN REAGENT by Derma Media Lab., Inc. — Product Code CIG

K955940 is an FDA 510(k) premarket notification submitted by Derma Media Lab., Inc. for the device "TOTAL BILIRUBIN REAGENT". The FDA issued a decision of Substantially Equivalent on March 13, 1996. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Derma Media Lab., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1996
Date Received
December 21, 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 Derma Media Lab., Inc.

  • K970664 — GLUCOSE REAGENT (August 1, 1997)
  • K971309 — UREA (August 1, 1997)
  • K971072 — CHOLESTEROL REAGENT (June 20, 1997)
  • K970867 — URIC ACID REAGENT (April 21, 1997)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K964915 — MAGNESIUM (March 26, 1997)
  • K964913 — IRON REAGENT (February 20, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (February 4, 1997)
  • K965126 — AST/SGOT (January 17, 1997)

Other clearances for product code CIG

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) (June 12, 2023)
  • K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil) (March 20, 2023)
  • K223324 — Total Bilirubin2 (December 29, 2022)
  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • 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)

FDA data resources