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FDA 510(k)

BLASTOMYCES DERMATITIDIS POS/CONTROL

K-Number: K792681 · 1980-01-17

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-17
Product CodeKFH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BLASTOMYCES DERMATITIDIS POS/CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K792681. The device is classified under product code KFH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLASTOMYCES DERMATITIDIS POS/CONTROL?

BLASTOMYCES DERMATITIDIS POS/CONTROL is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792681.

When did BLASTOMYCES DERMATITIDIS POS/CONTROL receive FDA 510(k) clearance?

BLASTOMYCES DERMATITIDIS POS/CONTROL received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792681.

Who is the listed applicant for BLASTOMYCES DERMATITIDIS POS/CONTROL?

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

What is the FDA product code for BLASTOMYCES DERMATITIDIS POS/CONTROL?

The FDA product code for BLASTOMYCES DERMATITIDIS POS/CONTROL is KFH.

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Other records listing Meridian Diagnostics, 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: KFH)

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.

K880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001Immuno-Mycologics, Inc.K792685BLASTOMYCES DERMATITIDIS, ANTISERUMMeridian Diagnostics, Inc.K760833ANTI-BLASTOMYCES CONTROL SERUM (YEAST)I M, Inc.

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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