Cleared Traditional

K923598 - REDI-CHECK PHOTMETER Q.A.

K923598 is an FDA 510(k) clearance for REDI-CHECK PHOTMETER Q.A., manufactured by Awareness Technology, Inc.. The device is a Class 2 Chemistry device with product code JFS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K923598 · Awareness Technology, Inc. · Chemistry device
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Oct 1992
Decision
86d
Days
Class 2
Risk

K923598 is an FDA 510(k) clearance for the REDI-CHECK PHOTMETER Q.A.. Classified as Coulometric, Chloride (product code JFS), Class II - Special Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on October 14, 1992 after a review of 86 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 Awareness Technology, Inc. devices

FDA 510(k) Submission Details - K923598

510(k) Number K923598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date October 14, 1992
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFS Device Classification - Class 2, Special Controls

Product Code JFS Coulometric, 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 - JFS Coulometric, Chloride

All 12
Devices cleared under the same product code (JFS) and FDA review panel - the closest regulatory comparables to K923598.
REAGENTS CORNING CHLORIDE METER FOR
K830217 · Fisher Scientific Co., LLC · Feb 1983
LIQUIZYME CHLORIDE REAGENT
K820411 · American Research Products Co. · Mar 1982
SILVER ANODE
K810550 · Nobel Scientific Industries, Inc. · Apr 1981
CORNING 925 CHLORIDE METER
K810615 · Corning Medical & Scientific · Mar 1981
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · J.T. Baker Chemical Co. · Oct 1980
NSI CHLORIDE REAGENT KIT
K800585 · Nobel Scientific Industries, Inc. · Apr 1980