Cleared Traditional

K830217 - REAGENTS CORNING CHLORIDE METER FOR

K830217 is an FDA 510(k) clearance for REAGENTS CORNING CHLORIDE METER FOR, manufactured by Fisher Scientific Co., LLC. The device is a Class 2 Chemistry device with product code JFS cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K830217 · Fisher Scientific Co., LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
25d
Days
Class 2
Risk

K830217 is an FDA 510(k) clearance for the REAGENTS CORNING CHLORIDE METER FOR. 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 18, 1983 after a review of 25 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.

FDA 510(k) Submission Details - K830217

510(k) Number K830217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1983
Decision Date February 18, 1983
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
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 18
Devices cleared under the same product code (JFS) and FDA review panel - the closest regulatory comparables to K830217.
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
K121823 · Wescor, Inc. · Mar 2013
REDI-CHECK PHOTMETER Q.A.
K923598 · Awareness Technology, Inc. · Oct 1992
CHLORIDE REAGENT KIT
K873127 · A-Kem, Inc. · Oct 1987
RERMCO TEST CHLORIDE REAGENT
K823106 · Fermco Biochemics, Inc. · Nov 1982
LIQUIZYME CHLORIDE REAGENT
K820411 · American Research Products Co. · Mar 1982
CHLORIDE REAGENT KIT
K811319 · Chem-Elec, Inc. · Aug 1981
K830217 · REAGENTS CORNING CHLORIDE METER FOR
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