Cleared Traditional

K873257 - GENERAL PURPOSE MEDIA W/SELECT. & DIFF....

K873257 is an FDA 510(k) clearance for GENERAL PURPOSE MEDIA W/SELECT. & DIFF...., manufactured by Central Media. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K873257 · Central Media · Microbiology device
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Nov 1987
Decision
87d
Days
Class 1
Risk

K873257 is an FDA 510(k) clearance for the GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA.. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Central Media (Sacramento, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Central Media devices

FDA 510(k) Submission Details - K873257

510(k) Number K873257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date November 06, 1987
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

JSG Device Classification - Class 1, General Controls

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 184
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