Cleared Traditional

OXYSTRIP (K930693) - FDA 510(k) Clearance

Class I Microbiology device.

K930693 · Hardy Diagnostics · Microbiology device
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May 1993
Decision
91d
Days
Class 1
Risk

K930693 is an FDA 510(k) clearance for the OXYSTRIP. 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 91 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 K930693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date May 12, 1993
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 243
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K930693.
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LD PRESUMPTO QUAD
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MS-2 BACTERIAL IDENTI. SYS
K830099 · Abbott Laboratories · Feb 1983
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1983