Cleared Traditional

K862168 - RAICHEM CHOLINESTERASE REAGENT

K862168 is the FDA 510(k) clearance for RAICHEM CHOLINESTERASE REAGENT by Reagents Applications, Inc.. It is a Class 1 Toxicology device (product code DIH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K862168 · Reagents Applications, Inc. · Toxicology device
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Jun 1986
Decision
18d
Days
Class 1
Risk

K862168 is an FDA 510(k) clearance for the RAICHEM CHOLINESTERASE REAGENT. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - the FDA toxicology device 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K862168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date June 27, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.