Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALPHA CRYPTOCOCCAL ANTIGEN EIA

K-Number: K120946 · 2012-12-17

ApplicantImmuno-Mycologics, Inc.
Decision Date2012-12-17
Product CodeMDU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALPHA CRYPTOCOCCAL ANTIGEN EIA 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 2012-12-17 under 510(k) number K120946. The device is classified under product code MDU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA CRYPTOCOCCAL ANTIGEN EIA?

ALPHA CRYPTOCOCCAL ANTIGEN EIA is a medical device that received FDA 510(k) clearance on 2012-12-17. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K120946.

When did ALPHA CRYPTOCOCCAL ANTIGEN EIA receive FDA 510(k) clearance?

ALPHA CRYPTOCOCCAL ANTIGEN EIA received FDA 510(k) clearance on 2012-12-17, under 510(k) number K120946.

Who is the listed applicant for ALPHA CRYPTOCOCCAL ANTIGEN EIA?

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 CRYPTOCOCCAL ANTIGEN EIA?

The FDA product code for ALPHA CRYPTOCOCCAL ANTIGEN EIA is MDU.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K112422CRAG LATERAL FLOW ASSAY (LFA)K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTK880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001K843286EI-CANDIDA ENZYME IMMUNOASSAY EI1001

View all 26 devices →

Related Devices (Code: MDU)

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.

K904393PREMIER-CRYPTOCOCCAL ANTIGENMeridian 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.

↑