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FDA 510(k)

RUBELISA TEST KIT

K-Number: K780996 · 1978-11-22

ApplicantMicrobiological Assoc.
Decision Date1978-11-22
Product CodeGON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Assoc.. It received FDA 510(k) clearance on 1978-11-22 under 510(k) number K780996. 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 RUBELISA TEST KIT?

RUBELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1978-11-22. The listed applicant is Microbiological Assoc.. The 510(k) number is K780996.

When did RUBELISA TEST KIT receive FDA 510(k) clearance?

RUBELISA TEST KIT received FDA 510(k) clearance on 1978-11-22, under 510(k) number K780996.

Who is the listed applicant for RUBELISA TEST KIT?

The FDA 510(k) record lists Microbiological Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBELISA TEST KIT?

The FDA product code for RUBELISA TEST KIT is GON.

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Other records listing Microbiological Assoc. 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.

K792133RUBELISA TEST KITK791397HERPES EIA TEST KITK781549TOXELISA TEST KITK781392CYTOMEGILISH TEST KITK781143IMMUNOFLUORESCENCE TEST KITK770764TISSUE CULTURE MEDIA W/HEPES BUFFER

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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.K802937RUBELLA VIRUS ANTIGENS & CONTROLSOrion Diagnostica, Inc.

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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