Cleared Traditional

K882262 - GLUCOSE-SUPER FAST 4983050 AND 4983500

K882262 is the FDA 510(k) clearance for GLUCOSE-SUPER FAST 4983050 AND 4983500 by American Research Products Co.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K882262 · American Research Products Co. · Chemistry device
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Feb 1989
Decision
247d
Days
Class 2
Risk

K882262 is an FDA 510(k) clearance for the GLUCOSE-SUPER FAST 4983050 AND 4983500. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on February 2, 1989 after a review of 247 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all American Research Products Co. devices

Submission Details

510(k) Number K882262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date February 02, 1989
Days to Decision 247 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
159d slower than avg
Panel avg: 88d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 196
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