Cleared Traditional

K820610 - GELRITE

K820610 is an FDA 510(k) clearance for GELRITE, manufactured by Kelco. The device is a Class 1 Microbiology device with product code JSK cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K820610 · Kelco · Microbiology device
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Oct 1982
Decision
233d
Days
Class 1
Risk

K820610 is an FDA 510(k) clearance for the GELRITE. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Kelco (Walker, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 233 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kelco devices

FDA 510(k) Submission Details - K820610

510(k) Number K820610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date October 27, 1982
Days to Decision 233 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 102d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

JSK Device Classification - Class 1, General Controls

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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 - JSK Supplement, Culture Media

All 66
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K820610.
MIDDLEBROOK ADC ENRICHMENT
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K831469 · Oxoid U.S.A., Inc. · Jun 1983
CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE
K831219 · Gibco Laboratories Life Technologies, Inc. · May 1983
YEAST AUTOLYXATE SUPPLEMENT
K822458 · Oxoid U.S.A., Inc. · Sep 1982
VCAT ANTIBIOTIC SUPPLEMENT
K822459 · Oxoid U.S.A., Inc. · Sep 1982
LCAT ANTIBIOTIC SUPPLEMENT
K822460 · Oxoid U.S.A., Inc. · Sep 1982