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FDA 510(k)

ADENOLEX (R) LATEX AGGLUTINATION TEST

K-Number: K864645 · 1987-06-04

ApplicantOrion Diagnostica, Inc.
Decision Date1987-06-04
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADENOLEX (R) LATEX AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1987-06-04 under 510(k) number K864645. The device is classified under product code GOD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADENOLEX (R) LATEX AGGLUTINATION TEST?

ADENOLEX (R) LATEX AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1987-06-04. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K864645.

When did ADENOLEX (R) LATEX AGGLUTINATION TEST receive FDA 510(k) clearance?

ADENOLEX (R) LATEX AGGLUTINATION TEST received FDA 510(k) clearance on 1987-06-04, under 510(k) number K864645.

Who is the listed applicant for ADENOLEX (R) LATEX AGGLUTINATION TEST?

The FDA 510(k) record lists Orion Diagnostica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADENOLEX (R) LATEX AGGLUTINATION TEST?

The FDA product code for ADENOLEX (R) LATEX AGGLUTINATION TEST is GOD.

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Other records listing Orion Diagnostica, 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.

K942286DIARLEX ROTA-ADENOK914892SALIVA-STIMK904655PYLORISETK884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GK884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MK884040IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

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Related Devices (Code: GOD)

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.

K110722RPS ADENO DETECTOR PLUSRapid Pathogen Screening, Inc.K052092RPS ADENO DETECTORRapid Pathogen ScreeningK990630SAS ADENO TESTSa Scientific, Inc.K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMImmunoprobe, Inc.K881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)Cambridge Bioscience Corp.K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.

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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