Cleared Traditional

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (K813342) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K813342 · Gamma Biologicals, Inc. · Chemistry device
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Mar 1982
Decision
99d
Days
Class 2
Risk

K813342 is an FDA 510(k) clearance for the GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION. Classified as Solution, Stabilized Enzyme (product code KSK), Class II - Special Controls.

Submitted by Gamma Biologicals, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.9400 - 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 Gamma Biologicals, Inc. devices

Submission Details

510(k) Number K813342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1981
Decision Date March 04, 1982
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSK Solution, Stabilized Enzyme
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9400
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.