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FDA 510(k)

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102

K-Number: K101407 · 2011-07-19

ApplicantImmuno-Mycologics, Inc.
Decision Date2011-07-19
Product CodeMIZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 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 2011-07-19 under 510(k) number K101407. The device is classified under product code MIZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102?

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K101407.

When did ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 receive FDA 510(k) clearance?

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 received FDA 510(k) clearance on 2011-07-19, under 510(k) number K101407.

Who is the listed applicant for ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102?

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 ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102?

The FDA product code for ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 is MIZ.

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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)K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTK880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001K843286EI-CANDIDA ENZYME IMMUNOASSAY EI1001

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Related Devices (Code: MIZ)

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.

K915700PERMIER HISTOPLASMAMeridian 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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