Cleared Traditional

K931414 - CATALASE REAGENT

K931414 is the FDA 510(k) clearance for CATALASE REAGENT by Hardy Diagnostics. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K931414 · Hardy Diagnostics · Microbiology device
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May 1993
Decision
90d
Days
Class 1
Risk

K931414 is an FDA 510(k) clearance for the CATALASE REAGENT. 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 May 12, 1993 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hardy Diagnostics devices

Submission Details

510(k) Number K931414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date May 12, 1993
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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 K931414.
BACTICARD STREP
K933514 · Remel Co. · Oct 1993
NINHYDRIN REAGENT
K931862 · Hardy Diagnostics · Jun 1993
OXYSTRIP
K930693 · Hardy Diagnostics · May 1993
BACTIDROP(TM) MUCAP
K930878 · Remel Co. · May 1993
FERRIC CHLORID REAGENT, 10%
K931413 · Hardy Diagnostics · May 1993
NITRATE REAGENTS A, B AND C
K930717 · Hardy Diagnostics · Apr 1993