Cleared Traditional

K823091 - H BROTH (FDA 510(k) Clearance)

Class I Pathology device.

K823091 · Granite Diagnostics, Inc. · Pathology device
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Nov 1982
Decision
17d
Days
Class 1
Risk

K823091 is an FDA 510(k) clearance for the H BROTH. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.2320 - the FDA pathology 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 K823091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date November 05, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 77d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
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.