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FDA 510(k)

RUBELLA BIO-BEAD SCREEN KIT

K-Number: K791610 · 1979-11-13

ApplicantLitton Bionetics
Decision Date1979-11-13
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA BIO-BEAD SCREEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Litton Bionetics. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K791610. The device is classified under product code GOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBELLA BIO-BEAD SCREEN KIT?

RUBELLA BIO-BEAD SCREEN KIT is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Litton Bionetics. The 510(k) number is K791610.

When did RUBELLA BIO-BEAD SCREEN KIT receive FDA 510(k) clearance?

RUBELLA BIO-BEAD SCREEN KIT received FDA 510(k) clearance on 1979-11-13, under 510(k) number K791610.

Who is the listed applicant for RUBELLA BIO-BEAD SCREEN KIT?

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

What is the FDA product code for RUBELLA BIO-BEAD SCREEN KIT?

The FDA product code for RUBELLA BIO-BEAD SCREEN KIT is GOL.

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Other records listing Litton Bionetics 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.

K840417EBNA ACIF KITK834443ROTAVIRUS BIO-ENZABEAD SCREEN KITK831343CMV RQ BIO-ENZABEAD KITK822985EBV-M KITK821804RUBELLA RQ BIO-ENZABEAD KITK801721HSV BIO-BEAD TITRATION KIT

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Related Devices (Code: GOL)

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.

K841174RUBELLA ANTIBODY FLUOROIMMUNOASSAYIntl. Diagnostic TechnologyK834032RUBAQUICK DIAGNOSTIC KITAbbott LaboratoriesK810309RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.K802339EIA RUBELLA-GBeckman Instruments, Inc.K802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.K802508RUBELISA IGM TEST KITM.A. Bioproducts

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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