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FDA 510(k)

EI-CANDIDA ENZYME IMMUNOASSAY EI1001

K-Number: K843286 · 1984-10-01

ApplicantImmuno-Mycologics, Inc.
Decision Date1984-10-01
Product CodeLRF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EI-CANDIDA ENZYME IMMUNOASSAY EI1001 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 1984-10-01 under 510(k) number K843286. The device is classified under product code LRF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EI-CANDIDA ENZYME IMMUNOASSAY EI1001?

EI-CANDIDA ENZYME IMMUNOASSAY EI1001 is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K843286.

When did EI-CANDIDA ENZYME IMMUNOASSAY EI1001 receive FDA 510(k) clearance?

EI-CANDIDA ENZYME IMMUNOASSAY EI1001 received FDA 510(k) clearance on 1984-10-01, under 510(k) number K843286.

Who is the listed applicant for EI-CANDIDA ENZYME IMMUNOASSAY EI1001?

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 EI-CANDIDA ENZYME IMMUNOASSAY EI1001?

The FDA product code for EI-CANDIDA ENZYME IMMUNOASSAY EI1001 is LRF.

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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: LRF)

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.

K883118ON THE SPOT CANDIDASUREMedi-Tech, Inc.K863499CANDIDATE(R) SUPERMercia Diagnostics , Ltd.

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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