Cleared Traditional

K821423 - MACCONKEY AGAR

K821423 is an FDA 510(k) clearance for MACCONKEY AGAR, manufactured by Interstate Media. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K821423 · Interstate Media · Microbiology device
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Jun 1982
Decision
20d
Days
Class 1
Risk

K821423 is an FDA 510(k) clearance for the MACCONKEY AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Interstate Media (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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: 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 Interstate Media devices

FDA 510(k) Submission Details - K821423

510(k) Number K821423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1982
Decision Date June 01, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 233
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K821423.
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K820798 · Biomedica, Inc. · Apr 1982