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FDA 510(k)

CRAG LATERAL FLOW ASSAY (CRAG LFA)

K-Number: K102286 · 2011-07-20

ApplicantImmuno-Mycologics, Inc.
Decision Date2011-07-20
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRAG LATERAL FLOW ASSAY (CRAG 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 2011-07-20 under 510(k) number K102286. 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 (CRAG LFA)?

CRAG LATERAL FLOW ASSAY (CRAG LFA) is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K102286.

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

CRAG LATERAL FLOW ASSAY (CRAG LFA) received FDA 510(k) clearance on 2011-07-20, under 510(k) number K102286.

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

The FDA product code for CRAG LATERAL FLOW ASSAY (CRAG 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 EIAK112422CRAG LATERAL FLOW ASSAY (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.

K112422CRAG LATERAL FLOW ASSAY (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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