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FDA 510(k)

ASPERGILLUS MYCELIAL ANTIGEN #CF10024X

K-Number: K791387 · 1979-08-16

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

Device Summary

ASPERGILLUS MYCELIAL ANTIGEN #CF10024X 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 K791387. The device is classified under product code JWT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPERGILLUS MYCELIAL ANTIGEN #CF10024X?

ASPERGILLUS MYCELIAL ANTIGEN #CF10024X 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 K791387.

When did ASPERGILLUS MYCELIAL ANTIGEN #CF10024X receive FDA 510(k) clearance?

ASPERGILLUS MYCELIAL ANTIGEN #CF10024X received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791387.

Who is the listed applicant for ASPERGILLUS MYCELIAL ANTIGEN #CF10024X?

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 ASPERGILLUS MYCELIAL ANTIGEN #CF10024X?

The FDA product code for ASPERGILLUS MYCELIAL ANTIGEN #CF10024X is JWT.

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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: JWT)

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.

K812740REAGENTS FOR SERODIAGNOSIS OF ASPERGILLNolan Biological Laboratories, Inc.K792700ASPERGILLUS SP, COMPLEMENT FIXATIONMeridian Diagnostics, Inc.K790672ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVUDiagnostica, Inc.K760830ASPERGILLUS 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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