Cleared Traditional

K792605 - CHLORIDE REAGENT

K792605 is the FDA 510(k) clearance for CHLORIDE REAGENT by Gilford Diagnostics. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K792605 · Gilford Diagnostics · Chemistry device
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Jan 1980
Decision
29d
Days
Class 2
Risk

K792605 is an FDA 510(k) clearance for the CHLORIDE REAGENT. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980 after a review of 29 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 Gilford Diagnostics devices

Submission Details

510(k) Number K792605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1979
Decision Date January 16, 1980
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 40
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K792605.
TECH. RA-1000 SYS SERUM CHLORIDE
K833746 · Technicon Instruments Corp. · Jan 1984
PROCEDURE 460 FOR DETERM. OF CHLORIDE
K833166 · Sigma Chemical Co. · Oct 1983
TPTZ CHLORIDE
K820235 · American Monitor Corp. · Feb 1982
ELVI CHLORIDE
K792400 · Volu Sol Medical Industries · Dec 1979
CHLORIDE TEST SET, CAT.# 0210
K781635 · Stanbio Laboratory · Oct 1978
REAGENT, CHLORIDE, COULTER
K770752 · Coulter Electronics, Inc. · Jun 1977