Cleared Traditional

K822999 - DNASE TEST AGAR W/TOLUIDINE BLUE

K822999 is the FDA 510(k) clearance for DNASE TEST AGAR W/TOLUIDINE BLUE by Granite Diagnostics, Inc.. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822999 · Granite Diagnostics, Inc. · Microbiology device
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Nov 1982
Decision
35d
Days
Class 1
Risk

K822999 is an FDA 510(k) clearance for the DNASE TEST AGAR W/TOLUIDINE BLUE. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982 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 Granite Diagnostics, Inc. devices

Submission Details

510(k) Number K822999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1982
Decision Date November 16, 1982
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 K822999.
CIN AGAR
K834327 · Hardy Media · Jan 1984
ANDRADES FERMENTATION MEDIA
K822995 · Granite Diagnostics, Inc. · Nov 1982
JORDANS TARTRATE AGAR
K822996 · Granite Diagnostics, Inc. · Nov 1982
MACATE BROTH
K823000 · Granite Diagnostics, Inc. · Nov 1982
PEPTONE IRON AGAR
K823001 · Granite Diagnostics, Inc. · Nov 1982
YEAST ASSIMILATION BROTH
K822694 · Granite Diagnostics, Inc. · Sep 1982