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FDA 510(k)

HISTOPLASMA YEAST ANTI #CF10021X

K-Number: K791393 · 1979-08-16

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

Device Summary

HISTOPLASMA YEAST ANTI #CF10021X 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 K791393. The device is classified under product code GMJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOPLASMA YEAST ANTI #CF10021X?

HISTOPLASMA YEAST ANTI #CF10021X 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 K791393.

When did HISTOPLASMA YEAST ANTI #CF10021X receive FDA 510(k) clearance?

HISTOPLASMA YEAST ANTI #CF10021X received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791393.

Who is the listed applicant for HISTOPLASMA YEAST ANTI #CF10021X?

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 HISTOPLASMA YEAST ANTI #CF10021X?

The FDA product code for HISTOPLASMA YEAST ANTI #CF10021X is GMJ.

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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: GMJ)

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.

K830837LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.K813359MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLAmerican Scientific ProductsK802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMNolan Biological Laboratories, Inc.K792701HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.K792711HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, 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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