Cleared Traditional

K930717 - NITRATE REAGENTS A

K930717 is the FDA 510(k) clearance for NITRATE REAGENTS A by Hardy Diagnostics. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K930717 · Hardy Diagnostics · Microbiology device
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Apr 1993
Decision
71d
Days
Class 1
Risk

K930717 is an FDA 510(k) clearance for the NITRATE REAGENTS A, B AND C. 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 23, 1993 after a review of 71 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 K930717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date April 23, 1993
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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 K930717.
CATALASE REAGENT
K931414 · Hardy Diagnostics · May 1993
BACTIDROP(TM) MUCAP
K930878 · Remel Co. · May 1993
FERRIC CHLORID REAGENT, 10%
K931413 · Hardy Diagnostics · May 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · Hardy Diagnostics · Apr 1993
VOGUES-PROSKAUER REAGENT A & B
K930720 · Hardy Diagnostics · Apr 1993
DRYSLIDE(TM) INDOLE
K925747 · Difco Laboratories, Inc. · Jan 1993