Cleared Traditional

K884013 - ROCHE REAGENT FOR CHLORIDE

K884013 is the FDA 510(k) clearance for ROCHE REAGENT FOR CHLORIDE by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K884013 · Roche Diagnostic Systems, Inc. · Chemistry device
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Dec 1988
Decision
78d
Days
Class 2
Risk

K884013 is an FDA 510(k) clearance for the ROCHE REAGENT FOR CHLORIDE. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K884013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1988
Decision Date December 09, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 33
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K884013.
BIOTROL CHLORIDE
K890015 · Biotrol, USA, Inc. · Feb 1989
TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE
K884601 · Technicon Instruments Corp. · Jan 1989
CHLORIDE TEST (CL) ITEM #65659
K884706 · Em Diagnostic Systems, Inc. · Jan 1989
CHLORIDE LIQUID STABLE REAGENT SET
K881200 · Medical Analysis Systems, Inc. · Apr 1988
CHLORIDE CAT. # 152-17
K875208 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
CHLORIDE REAGENT - THIOCYANATE METHOD
K870367 · Trace Scientific , Ltd. · Aug 1987