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510(k) K023330

BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 by Diagnostic Chemicals , Ltd. — Product Code CIG

K023330 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30". The FDA issued a decision of Substantially Equivalent on December 11, 2002. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Diagnostic Chemicals , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2002
Date Received
October 4, 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 Diagnostic Chemicals , Ltd.

  • K070383 — ENZYMATIC CREATININE ASSAY (265 SERIES) (June 22, 2007)
  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (January 19, 2007)
  • K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (April 28, 2006)
  • K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (April 24, 2006)
  • K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (November 10, 2005)
  • K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20 (July 5, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- (December 27, 2004)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K041928 — HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (November 23, 2004)

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