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FDA 510(k)

DERMATOPHYTIN O

K-Number: K790671 · 1979-05-31

ApplicantDiagnostica, Inc.
Decision Date1979-05-31
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DERMATOPHYTIN O is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1979-05-31 under 510(k) number K790671. 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 DERMATOPHYTIN O?

DERMATOPHYTIN O is a medical device that received FDA 510(k) clearance on 1979-05-31. The listed applicant is Diagnostica, Inc.. The 510(k) number is K790671.

When did DERMATOPHYTIN O receive FDA 510(k) clearance?

DERMATOPHYTIN O received FDA 510(k) clearance on 1979-05-31, under 510(k) number K790671.

Who is the listed applicant for DERMATOPHYTIN O?

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

What is the FDA product code for DERMATOPHYTIN O?

The FDA product code for DERMATOPHYTIN O is JXB.

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Other records listing Diagnostica, Inc. as applicant

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.

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Related Devices (Code: JXB)

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.

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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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