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FDA 510(k)

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION

K-Number: K791382 · 1979-08-16

ApplicantImmuno-Mycologics, Inc.
Decision Date1979-08-16
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION 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 1979-08-16 under 510(k) number K791382. 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 CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION?

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K791382.

When did CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION receive FDA 510(k) clearance?

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791382.

Who is the listed applicant for CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION?

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 CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION?

The FDA product code for CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION 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)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: 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.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 Products

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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