Cleared Traditional

CHROMAGAR CANDIDA (K960075) - FDA 510(k) Clearance

Class I Microbiology device.

K960075 · Hardy Diagnostics · Microbiology device
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Aug 1996
Decision
204d
Days
Class 1
Risk

K960075 is an FDA 510(k) clearance for the CHROMAGAR CANDIDA. Classified as Kit, Screening, Yeast (product code JXC), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on August 2, 1996 after a review of 204 days - an extended review 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: 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.

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Submission Details

510(k) Number K960075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date August 02, 1996
Days to Decision 204 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
102d slower than avg
Panel avg: 102d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXC Kit, Screening, Yeast
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.