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510(k) K881241

TOTAL BILIRUBIN REAGENT by Tech-Neal Scientific, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
March 22, 1988
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 Tech-Neal Scientific, Inc.

  • K882256 — MAGNESIUM REAGENT SET (August 8, 1988)
  • K882459 — DIAZO, COLORIMETRIC BILIRUBIN (August 2, 1988)
  • K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET (May 31, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880844 — ALBUMIN REAGENT SET (April 5, 1988)
  • K880842 — LDH-L REAGENT SET (April 5, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)

Other clearances for product code CIG

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  • 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)