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FDA 510(k)

ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM

K-Number: K791386 · 1979-08-16

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

Device Summary

ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM 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 K791386. The device is classified under product code KFG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM?

ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM 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 K791386.

When did ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM receive FDA 510(k) clearance?

ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791386.

Who is the listed applicant for ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM?

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 ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM?

The FDA product code for ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM is KFG.

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Other records listing Immuno-Mycologics, Inc. as applicant

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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: KFG)

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.

K904499NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)Ackrad LaboratoriesK792698ASPERGILLUS SP, ANTISERUM, POSITIVEMeridian Diagnostics, Inc.K792686ASPERGILLUS SP, ANTISERUM POSITIVEMeridian Diagnostics, Inc.K760835ANTI-ASPERGILLUS 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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