Cleared Traditional

K781132 - CHEMLAR

K781132 is an FDA 510(k) clearance for CHEMLAR, manufactured by Hi Chem, Inc.. The device is a Class 2 Chemistry device with product code JFS cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K781132 · Hi Chem, Inc. · Chemistry device
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Aug 1978
Decision
38d
Days
Class 2
Risk

K781132 is an FDA 510(k) clearance for the CHEMLAR. Classified as Coulometric, Chloride (product code JFS), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 38 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 - K781132

510(k) Number K781132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 10, 1978
Days to Decision 38 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
51d faster than avg
Panel avg: 89d · This submission: 38d
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 K781132.
CHOLORDE REAGENT
K791690 · Hi Chem, Inc. · Sep 1979
REAGENT KIT, CHLORIDE/CARBON DIOXIDE
K790045 · J.T. Baker Chemical Co. · Feb 1979
CHLORIDE/CARBON DIOXIDE REAGENT SET
K781275 · Nobel Scientific Industries, Inc. · Aug 1978
CHLORIDE
K771832 · Gamma Enterprises, Inc. · Nov 1977
REAGENT, CHLORIDOMETER ACID
K760394 · Bulcher Instruments · Nov 1976
K781132 · CHEMLAR
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