Cleared Traditional

K884176 - CHROMATOGRAPHY KIT

K884176 is an FDA 510(k) clearance for CHROMATOGRAPHY KIT, manufactured by Gelman Sciences, Inc.. The device is a Class 1 Toxicology device with product code DPA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K884176 · Gelman Sciences, Inc. · Toxicology device
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Apr 1989
Decision
182d
Days
Class 1
Risk

K884176 is an FDA 510(k) clearance for the CHROMATOGRAPHY KIT. Classified as Apparatus, General Use, Thin Layer Chromatography (product code DPA), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on April 4, 1989 after a review of 182 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2270 - 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.

FDA 510(k) Submission Details - K884176

510(k) Number K884176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date April 04, 1989
Days to Decision 182 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
95d slower than avg
Panel avg: 87d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

DPA Device Classification - Class 1, General Controls

Product Code DPA Apparatus, General Use, Thin Layer Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2270
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.

Regulatory Peers - DPA Apparatus, General Use, Thin Layer Chromatography

Devices cleared under the same product code (DPA) and FDA review panel - the closest regulatory comparables to K884176.
DE-TOX TUBES A AND DE-TOX TUBES B
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TECHNICON FAST-LC SYS. FOR THEOPHYLLINE
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K770765 · G.D. Searle and Co. · Jun 1977
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K760908 · Ackerman Nuclear, Inc. · Nov 1976
K884176 · CHROMATOGRAPHY KIT
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