510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032311Substantially Equivalent

Roche Diagnostics Omni S Analyzer

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

K032311 is the FDA 510(k) clearance record for ROCHE DIAGNOSTICS OMNI S ANALYZER, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show 9 recalls naming K032311.

Clearance record

Decision date
Received
(81 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. P.O. Box 50457, Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEM

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