Cleared Traditional

K882117 - ETHYL ALCOHOL STANDARD

K882117 is the FDA 510(k) clearance for ETHYL ALCOHOL STANDARD by Verichem Laboratories, Inc.. It is a Class 2 Toxicology device (product code DNN) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K882117 · Verichem Laboratories, Inc. · Toxicology device
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Aug 1988
Decision
77d
Days
Class 2
Risk

K882117 is an FDA 510(k) clearance for the ETHYL ALCOHOL STANDARD. Classified as Calibrators, Ethyl Alcohol (product code DNN), Class II - Special Controls.

Submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Verichem Laboratories, Inc. devices

Submission Details

510(k) Number K882117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date August 04, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DNN Calibrators, Ethyl Alcohol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DNN Calibrators, Ethyl Alcohol

Devices cleared under the same product code (DNN) and FDA review panel - the closest regulatory comparables to K882117.
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K990516 · Emd Chemicals, Inc. · Mar 1999
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K973054 · Emd Chemicals, Inc. · Oct 1997
ETHYL ALCOHOL CALIBRATORS & CONTROL
K924733 · Diagnostic Reagents, Inc. · Dec 1992
ETHYL ALCOHOL SERUM CALIBRATOR
K810466 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR
K802620 · Syva Co. · Oct 1980