Cleared Traditional

K882789 - COON'S MEDIUM F-12

K882789 is the FDA 510(k) clearance for COON'S MEDIUM F-12 by J R Scientific. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K882789 · J R Scientific · Pathology device
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Jul 1988
Decision
12d
Days
Class 1
Risk

K882789 is an FDA 510(k) clearance for the COON'S MEDIUM F-12, CATALOG NO. 200-2066. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by J R Scientific (Woodland, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all J R Scientific devices

Submission Details

510(k) Number K882789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1988
Decision Date July 18, 1988
Days to Decision 12 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 77d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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 - KIT Media And Components, Synthetic Cell And Tissue Culture

All 304
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K882789.
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2047
K882788 · J R Scientific · Jul 1988
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2042
K882790 · J R Scientific · Jul 1988
MCCOY'S 5A MEDIUM, CATA NO. 200-2026
K882773 · J R Scientific · Jul 1988
MEDIUM 199, CATALOG NO. 200-2032
K882806 · J R Scientific · Jul 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2011
K882807 · J R Scientific · Jul 1988
RPMI-1640 MEDIUM, CATALOG NO. 200-2076
K882808 · J R Scientific · Jul 1988