Cleared Traditional

K834327 - CIN AGAR

K834327 is the FDA 510(k) clearance for CIN AGAR by Hardy Media. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K834327 · Hardy Media · Microbiology device
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Jan 1984
Decision
35d
Days
Class 1
Risk

K834327 is an FDA 510(k) clearance for the CIN AGAR. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Hardy Media (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Hardy Media devices

Submission Details

510(k) Number K834327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1983
Decision Date January 13, 1984
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSF Culture Media, Single Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSF Culture Media, Single Biochemical Test

All 57
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K834327.
RIM SPOT INDOLE
K842097 · Austin Biological Laboratories · Jun 1984
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K841389 · Austin Biological Laboratories · May 1984
PORPHYRIN TEST AGAR
K840685 · Remel Co. · Apr 1984
ANDRADES FERMENTATION MEDIA
K822995 · Granite Diagnostics, Inc. · Nov 1982
JORDANS TARTRATE AGAR
K822996 · Granite Diagnostics, Inc. · Nov 1982
DNASE TEST AGAR W/TOLUIDINE BLUE
K822999 · Granite Diagnostics, Inc. · Nov 1982