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FDA 510(k)

ADENO VIRUS & CONTROLS

K-Number: K802929 · 1980-12-31

ApplicantOrion Diagnostica, Inc.
Decision Date1980-12-31
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADENO VIRUS & CONTROLS 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 1980-12-31 under 510(k) number K802929. 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 ADENO VIRUS & CONTROLS?

ADENO VIRUS & CONTROLS is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802929.

When did ADENO VIRUS & CONTROLS receive FDA 510(k) clearance?

ADENO VIRUS & CONTROLS received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802929.

Who is the listed applicant for ADENO VIRUS & CONTROLS?

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 ADENO VIRUS & CONTROLS?

The FDA product code for ADENO VIRUS & CONTROLS is GOD.

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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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