Cleared Traditional

K823139 - SMITH'S MEDIUM

K823139 is the FDA 510(k) clearance for SMITH'S MEDIUM by Granite Diagnostics, Inc.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K823139 · Granite Diagnostics, Inc. · Microbiology device
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Dec 1982
Decision
39d
Days
Class 1
Risk

K823139 is an FDA 510(k) clearance for the SMITH'S MEDIUM. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 39 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 Granite Diagnostics, Inc. devices

Submission Details

510(k) Number K823139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date December 03, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 102d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-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 - JSJ Culture Media, Selective And Non-differential

All 239
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K823139.
MYCOBIOTIC AGAR
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BILE ESCULIN AGAR
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SCHAEDLER AGARS
K823248 · Granite Diagnostics, Inc. · Dec 1982
CORN MEAL AGAR W/POLYSORBATE 80
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CIN AGAR MEDIUM
K823050 · Gibco Laboratories Life Technologies, Inc. · Nov 1982