Cleared Traditional

K851582 - GN BROTH

K851582 is an FDA 510(k) clearance for GN BROTH, manufactured by Preferred Micro-Media. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K851582 · Preferred Micro-Media · Microbiology device
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May 1985
Decision
16d
Days
Class 1
Risk

K851582 is an FDA 510(k) clearance for the GN BROTH. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Preferred Micro-Media (Toledo, US). The FDA issued a Cleared decision on May 2, 1985 after a review of 16 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 Preferred Micro-Media devices

FDA 510(k) Submission Details - K851582

510(k) Number K851582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date May 02, 1985
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

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 271
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K851582.
SELECTIVE STREPTOCOCCUS AGAR
K851593 · Preferred Micro-Media · May 1985
TRICHOMONAS BROTH (KUPFORBERG
K851599 · Preferred Micro-Media · May 1985
COLUMBIZ CNA AGAR W/5% SHEEP BLOOD
K851580 · Preferred Micro-Media · May 1985
MYCOLOGY AGAR W/ANTIBOTICS
K851590 · Preferred Micro-Media · Apr 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
K851249 · Roche Diagnostic Systems, Inc. · Apr 1985
KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR
K851347 · Micro Media Laboratories · Apr 1985