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FDA 510(k)

CAPIK-CANDIDA ALBICANS IDENT. KIT.

K-Number: K800908 · 1980-06-02

ApplicantImmuno-Mycologics, Inc.
Decision Date1980-06-02
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CAPIK-CANDIDA ALBICANS IDENT. KIT. is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Mycologics, Inc.. It received FDA 510(k) clearance on 1980-06-02 under 510(k) number K800908. The device is classified under product code JXB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIK-CANDIDA ALBICANS IDENT. KIT.?

CAPIK-CANDIDA ALBICANS IDENT. KIT. is a medical device that received FDA 510(k) clearance on 1980-06-02. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K800908.

When did CAPIK-CANDIDA ALBICANS IDENT. KIT. receive FDA 510(k) clearance?

CAPIK-CANDIDA ALBICANS IDENT. KIT. received FDA 510(k) clearance on 1980-06-02, under 510(k) number K800908.

Who is the listed applicant for CAPIK-CANDIDA ALBICANS IDENT. KIT.?

The FDA 510(k) record lists Immuno-Mycologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPIK-CANDIDA ALBICANS IDENT. KIT.?

The FDA product code for CAPIK-CANDIDA ALBICANS IDENT. KIT. is JXB.

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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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