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FDA 510(k)

COCCIDIODES (COCCI)

K-Number: K791381 · 1979-08-16

ApplicantImmuno-Mycologics, Inc.
Decision Date1979-08-16
Product CodeGMG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COCCIDIODES (COCCI) 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 1979-08-16 under 510(k) number K791381. The device is classified under product code GMG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCCIDIODES (COCCI)?

COCCIDIODES (COCCI) is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K791381.

When did COCCIDIODES (COCCI) receive FDA 510(k) clearance?

COCCIDIODES (COCCI) received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791381.

Who is the listed applicant for COCCIDIODES (COCCI)?

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 COCCIDIODES (COCCI)?

The FDA product code for COCCIDIODES (COCCI) is GMG.

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Other records listing Immuno-Mycologics, 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.

K120946ALPHA CRYPTOCOCCAL ANTIGEN EIAK112422CRAG LATERAL FLOW ASSAY (LFA)K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTK880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001

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Related Devices (Code: GMG)

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.

K812189COCCIDIOIDES LATEX AGGLUTINATIONAmerican Scientific ProductsK792690COCCIDIOIDES IMMITIS, LATEX AGGLUTIMeridian Diagnostics, Inc.K782070REAGENT, COCCI LATEXI M, Inc.K760829COCCIDIOIDES MYCELIAL ANTIGENI 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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