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FDA 510(k)

COCCIDIOIDES IMMITIS, ANTISERUM POS.

K-Number: K792717 · 1980-01-17

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

Device Summary

COCCIDIOIDES IMMITIS, ANTISERUM POS. 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 K792717. The device is classified under product code GMH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCCIDIOIDES IMMITIS, ANTISERUM POS.?

COCCIDIOIDES IMMITIS, ANTISERUM POS. 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 K792717.

When did COCCIDIOIDES IMMITIS, ANTISERUM POS. receive FDA 510(k) clearance?

COCCIDIOIDES IMMITIS, ANTISERUM POS. received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792717.

Who is the listed applicant for COCCIDIOIDES IMMITIS, ANTISERUM POS.?

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 COCCIDIOIDES IMMITIS, ANTISERUM POS.?

The FDA product code for COCCIDIOIDES IMMITIS, ANTISERUM POS. is GMH.

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Other records listing Meridian Diagnostics, Inc. as applicant

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Related Devices (Code: GMH)

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.

K792688COCCIDIOIDES IMMITIS, ANTISERUMMeridian Diagnostics, Inc.K792684COCCIDIOIDES IMMITIS, ANTISERUM,Meridian Diagnostics, Inc.K791388ANTI-COCCIDIOIDES SERUM #CF10028XImmuno-Mycologics, Inc.K760834ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)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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