510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063543Substantially Equivalent

Cobas Integra Bilirubin Special and Roche/hitachi Bilrubin Total, Models 20737496 322, 03261638 190, and 11822713 226

Roche Diagnostics GmbH, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063543 is the FDA 510(k) clearance record for COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K063543.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260