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FDA 510(k)

RUBELLA VIRUS ANTIGENS & CONTROLS

K-Number: K802937 · 1980-12-31

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

Device Summary

RUBELLA VIRUS ANTIGENS & 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 K802937. The device is classified under product code GON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBELLA VIRUS ANTIGENS & CONTROLS?

RUBELLA VIRUS ANTIGENS & 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 K802937.

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

RUBELLA VIRUS ANTIGENS & CONTROLS received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802937.

Who is the listed applicant for RUBELLA VIRUS ANTIGENS & 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 RUBELLA VIRUS ANTIGENS & CONTROLS?

The FDA product code for RUBELLA VIRUS ANTIGENS & CONTROLS is GON.

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Related Devices (Code: GON)

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.

K894262RUBELLA ANTIGEN AND CONTROL ANTIGENMicrobix Biosystems, Inc.K880157MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TESTSyva Co.K802939HERPES SIMPLEX TYPE IOrion Diagnostica, Inc.K780996RUBELISA TEST KITMicrobiological Assoc.

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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