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FDA 510(k)

CRAG LATERAL FLOW ASSAY (LFA)

K-Number: K112422 · 2012-03-28

ApplicantImmuno-Mycologics, Inc.
Decision Date2012-03-28
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRAG LATERAL FLOW ASSAY (LFA) 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 2012-03-28 under 510(k) number K112422. The device is classified under product code GMD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRAG LATERAL FLOW ASSAY (LFA)?

CRAG LATERAL FLOW ASSAY (LFA) is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K112422.

When did CRAG LATERAL FLOW ASSAY (LFA) receive FDA 510(k) clearance?

CRAG LATERAL FLOW ASSAY (LFA) received FDA 510(k) clearance on 2012-03-28, under 510(k) number K112422.

Who is the listed applicant for CRAG LATERAL FLOW ASSAY (LFA)?

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 CRAG LATERAL FLOW ASSAY (LFA)?

The FDA product code for CRAG LATERAL FLOW ASSAY (LFA) is GMD.

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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 EIAK102286CRAG LATERAL FLOW ASSAY (CRAG LFA)K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTK880029EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001K843286EI-CANDIDA ENZYME IMMUNOASSAY EI1001

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Related Devices (Code: GMD)

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.

K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)Immuno-Mycologics, Inc.K930418CRYPTO-LEX SYSTEMTrinity Laboratories, Inc.K933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYAlexon Biomedical, Inc.K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMeridian Diagnostics, Inc.K812188CRYPTOCOCCAL ANTIGEN LATEX AGGLUTIAmerican Scientific ProductsK810510YA-CRYPTO ANTIBODY TUBE AGGLUTINATIONImmuno-Mycologics, 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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