510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850334Substantially Equivalent

Roche Reagent for Chloride, for the Cobas

Roche Diagnostic Systems, Inc., Nutley NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850334 is the FDA 510(k) clearance record for ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K850334.

Clearance record

Decision date
Received
(45 days to decision)
Product code
CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Regulation
21 CFR 862.1170
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostic Systems, Inc. Div. Of Hoffmann-La Roche, Inc, Nutley NJ
Third party review
No

Clearances, product code CHJ

Trailing 12 months

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

FDA records show no clearances under product code CHJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CHJ, 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