Cleared Traditional

K960996 - M. CAT BUTYRATE DISK

K960996 is the FDA 510(k) clearance for M. CAT BUTYRATE DISK by Hardy Diagnostics. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K960996 · Hardy Diagnostics · Microbiology device
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Apr 1996
Decision
37d
Days
Class 1
Risk

K960996 is an FDA 510(k) clearance for the M. CAT BUTYRATE DISK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Diagnostics devices

Submission Details

510(k) Number K960996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date April 18, 1996
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 102d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K960996.
COLISCREEN
K961191 · Hardy Diagnostics · Jun 1996
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K954783 · Difco Laboratories, Inc. · Feb 1996
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K941016 · Difco Laboratories, Inc. · Jun 1994
BACTICARD STREP
K936021 · Remel Co. · May 1994
BACTICARD E. COLI
K934986 · Remel Co. · Feb 1994
PYR TEST KIT
K931865 · Hardy Diagnostics · Dec 1993