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510(k) K024116

WIENER LAB. BILIRUBINA DIRECT AA by Wiener Laboratories Saic — Product Code CIG

K024116 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB. BILIRUBINA DIRECT AA". The FDA issued a decision of Substantially Equivalent on February 12, 2003. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2003
Date Received
December 13, 2002
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 Wiener Laboratories Saic

  • K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (February 11, 2004)
  • K024305 — WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 (March 18, 2003)
  • K023992 — WIENER LAB COLINESTERASA AA (February 12, 2003)
  • K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (January 3, 2003)
  • K023549 — WIENER LAB AMILASA 405 AA LIQUIDA (December 9, 2002)
  • K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA (December 9, 2002)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K022962 — WIENER LAB. BILIRRUBINA TOTAL AA (November 1, 2002)
  • K021334 — WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB. (September 10, 2002)
  • K021332 — WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV A (July 3, 2002)

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