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FDA 510(k)

YA-CRYPTO ANTIBODY TUBE AGGLUTINATION

K-Number: K810510 · 1981-03-20

ApplicantImmuno-Mycologics, Inc.
Decision Date1981-03-20
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

YA-CRYPTO ANTIBODY TUBE 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 1981-03-20 under 510(k) number K810510. 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 YA-CRYPTO ANTIBODY TUBE AGGLUTINATION?

YA-CRYPTO ANTIBODY TUBE AGGLUTINATION is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Immuno-Mycologics, Inc.. The 510(k) number is K810510.

When did YA-CRYPTO ANTIBODY TUBE AGGLUTINATION receive FDA 510(k) clearance?

YA-CRYPTO ANTIBODY TUBE AGGLUTINATION received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810510.

Who is the listed applicant for YA-CRYPTO ANTIBODY TUBE 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 YA-CRYPTO ANTIBODY TUBE AGGLUTINATION?

The FDA product code for YA-CRYPTO ANTIBODY TUBE 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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