Cleared Traditional

K884177 - DRUG STANDARD SET

K884177 is the FDA 510(k) clearance for DRUG STANDARD SET by Gelman Sciences, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K884177 · Gelman Sciences, Inc. · Toxicology device
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Feb 1989
Decision
136d
Days
Class 2
Risk

K884177 is an FDA 510(k) clearance for the DRUG STANDARD SET. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gelman Sciences, Inc. devices

Submission Details

510(k) Number K884177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date February 17, 1989
Days to Decision 136 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
49d slower than avg
Panel avg: 87d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
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 - DKB Calibrators, Drug Mixture

All 79
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K884177.
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K872392 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1987
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K843507 · Syva Co. · Sep 1984