510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884013Substantially Equivalent

Roche Reagent for Chloride

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

K884013 is the FDA 510(k) clearance record for ROCHE REAGENT FOR CHLORIDE, 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 K884013.

Clearance record

Decision date
Received
(78 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. One Sunset Ave., Montclair 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