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510(k) K981289

N-ASSAY L T-BIL by Crestat Diagnostics, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1998
Date Received
April 8, 1998
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 Crestat Diagnostics, Inc.

  • K980883 — N-ASSAY GLU-UL (September 3, 1998)
  • K981276 — N-ASSAY L D-BIL (May 1, 1998)
  • K980900 — N-ASSAY CPK-L (March 26, 1998)
  • K980902 — N-ASSAY L AST/GOT (March 26, 1998)
  • K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT (October 20, 1997)
  • K971985 — N-ASSAY TIA PLASMINOGEN TEST KIT (October 20, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964298 — N-ASSAY TIA MULTI V-NL (July 14, 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)