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FDA 510(k)

CHROMAGAR CANDIDA

K-Number: K960075 · 1996-08-02

ApplicantHardy Diagnostics
Decision Date1996-08-02
Product CodeJXC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHROMAGAR CANDIDA is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1996-08-02 under 510(k) number K960075. The device is classified under product code JXC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMAGAR CANDIDA?

CHROMAGAR CANDIDA is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is Hardy Diagnostics. The 510(k) number is K960075.

When did CHROMAGAR CANDIDA receive FDA 510(k) clearance?

CHROMAGAR CANDIDA received FDA 510(k) clearance on 1996-08-02, under 510(k) number K960075.

Who is the listed applicant for CHROMAGAR CANDIDA?

The FDA 510(k) record lists Hardy Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMAGAR CANDIDA?

The FDA product code for CHROMAGAR CANDIDA is JXC.

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Related Devices (Code: JXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K913426ALBICANS SUREJrga DiagnosticsK884720GERM TUBE SOLUTIONRemel Co.K891476C. ALBICANS SCREENCarr-Scarborough Microbiologicals, Inc.K882371SOC SLIDE CULTURE SYSTEMThe Cancer Center AT Wadley InstitutesK832406QUANTUM II YEAST IDENT. SYSTEMAbbott Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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