Cleared Traditional

K802080 - BAKER DIAG. ULTRARATE CHLORIDE KIT

K802080 is the FDA 510(k) clearance for BAKER DIAG. ULTRARATE CHLORIDE KIT by J.T. Baker Chemical Co.. It is a Class 2 Chemistry device (product code JFS) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K802080 · J.T. Baker Chemical Co. · Chemistry device
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Oct 1980
Decision
43d
Days
Class 2
Risk

K802080 is an FDA 510(k) clearance for the BAKER DIAG. ULTRARATE CHLORIDE KIT. Classified as Coulometric, Chloride (product code JFS), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 43 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 J.T. Baker Chemical Co. devices

Submission Details

510(k) Number K802080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1980
Decision Date October 10, 1980
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (JFS) and FDA review panel - the closest regulatory comparables to K802080.
REAGENTS CORNING CHLORIDE METER FOR
K830217 · Fisher Scientific Co., LLC · Feb 1983
LIQUIZYME CHLORIDE REAGENT
K820411 · American Research Products Co. · Mar 1982
CORNING 925 CHLORIDE METER
K810615 · Corning Medical & Scientific · Mar 1981
CHLORIDE REAGENT, CUP & CLEANER
K800217 · Fisher Scientific Co., LLC · Feb 1980
CHOLORDE REAGENT
K791690 · Hi Chem, Inc. · Sep 1979
REAGENT KIT, CHLORIDE/CARBON DIOXIDE
K790045 · J.T. Baker Chemical Co. · Feb 1979