Cleared Traditional

K960075 - CHROMAGAR CANDIDA

K960075 is an FDA 510(k) clearance for CHROMAGAR CANDIDA, manufactured by Hardy Diagnostics. The device is a Class 1 Microbiology device with product code JXC cleared through the Traditional 510(k) pathway after a 204-day FDA review.

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.

FDA 510(k) Submission Details - K960075

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 102d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

JXC Device Classification - Class 1, General Controls

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.

Regulatory Peers - JXC Kit, Screening, Yeast

Devices cleared under the same product code (JXC) and FDA review panel - the closest regulatory comparables to K960075.
ALBICANS SURE
K913426 · Jrga Diagnostics · Apr 1992
GERM TUBE SOLUTION
K884720 · Remel Co. · Jun 1989
C. ALBICANS SCREEN
K891476 · Carr-Scarborough Microbiologicals, Inc. · Apr 1989
SOC SLIDE CULTURE SYSTEM
K882371 · The Cancer Center AT Wadley Institutes · Jul 1988
QUANTUM II YEAST IDENT. SYSTEM
K832406 · Abbott Laboratories · Sep 1983
K960075 · CHROMAGAR CANDIDA
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