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510(k) K884224

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS by A-Kem, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1988
Date Received
October 6, 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 A-Kem, Inc.

  • K884227 — CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (December 9, 1988)
  • K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K884225 — TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K882587 — A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K882586 — A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (August 8, 1988)
  • K873128 — GLUCOSE REAGENT KIT (October 23, 1987)
  • K873130 — WASH SOLUTION KIT (October 23, 1987)
  • K873127 — CHLORIDE REAGENT KIT (October 23, 1987)
  • K873132 — BUN REAGENT KIT (October 23, 1987)
  • K873126 — SODIUM/POTASSIUM REAGENT KIT (October 23, 1987)

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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)