510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040174Substantially Equivalent

Bilirubin Assay on the Omni S Analyzer

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

K040174 is the FDA 510(k) clearance record for BILIRUBIN ASSAY ON THE OMNI S ANALYZER, a class I device, cleared for Roche Diagnostics Corp. on under FDA product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K040174.

Clearance record

Decision date
Received
(109 days to decision)
Product code
MQM Bilirubin (Total And Unbound) In The Neonate Test System
Regulation
21 CFR 862.1113
Device class
Class I
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 MQM

Trailing 12 months

FDA records hold no clearances under product code MQM in the trailing twelve months.

FDA records show no clearances under product code MQM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260