Cleared Traditional

K800217 - CHLORIDE REAGENT

K800217 is the FDA 510(k) clearance for CHLORIDE REAGENT by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code JFS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K800217 · Fisher Scientific Co., LLC · Chemistry device
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Feb 1980
Decision
22d
Days
Class 2
Risk

K800217 is an FDA 510(k) clearance for the CHLORIDE REAGENT, CUP & CLEANER. Classified as Coulometric, Chloride (product code JFS), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 22 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K800217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1980
Decision Date February 26, 1980
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K800217.
LIQUIZYME CHLORIDE REAGENT
K820411 · American Research Products Co. · Mar 1982
CORNING 925 CHLORIDE METER
K810615 · Corning Medical & Scientific · Mar 1981
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · J.T. Baker Chemical Co. · Oct 1980
CHOLORDE REAGENT
K791690 · Hi Chem, Inc. · Sep 1979
REAGENT KIT, CHLORIDE/CARBON DIOXIDE
K790045 · J.T. Baker Chemical Co. · Feb 1979
CHEMLAR
K781132 · Hi Chem, Inc. · Aug 1978