Cleared Traditional

K821599 - GRAM NEGATIVE BROTH

K821599 is the FDA 510(k) clearance for GRAM NEGATIVE BROTH by Hardy Media. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K821599 · Hardy Media · Microbiology device
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Jul 1982
Decision
47d
Days
Class 1
Risk

K821599 is an FDA 510(k) clearance for the GRAM NEGATIVE BROTH. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Hardy Media (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982 after a review of 47 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 Hardy Media devices

Submission Details

510(k) Number K821599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1982
Decision Date July 06, 1982
Days to Decision 47 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
55d faster than avg
Panel avg: 102d · This submission: 47d
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 K821599.
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K821596 · Hardy Media · Jul 1982
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