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FDA 510(k)

TEST FOR DETECTION OF ANTIRUBELLA ANTIB

K-Number: K760889 · 1976-11-16

ApplicantAbbott Laboratories
Decision Date1976-11-16
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TEST FOR DETECTION OF ANTIRUBELLA ANTIB is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1976-11-16 under 510(k) number K760889. 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 TEST FOR DETECTION OF ANTIRUBELLA ANTIB?

TEST FOR DETECTION OF ANTIRUBELLA ANTIB is a medical device that received FDA 510(k) clearance on 1976-11-16. The listed applicant is Abbott Laboratories. The 510(k) number is K760889.

When did TEST FOR DETECTION OF ANTIRUBELLA ANTIB receive FDA 510(k) clearance?

TEST FOR DETECTION OF ANTIRUBELLA ANTIB received FDA 510(k) clearance on 1976-11-16, under 510(k) number K760889.

Who is the listed applicant for TEST FOR DETECTION OF ANTIRUBELLA ANTIB?

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

What is the FDA product code for TEST FOR DETECTION OF ANTIRUBELLA ANTIB?

The FDA product code for TEST FOR DETECTION OF ANTIRUBELLA ANTIB is GOL.

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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.K802508RUBELISA IGM TEST KITM.A. BioproductsK802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.K802339EIA RUBELLA-GBeckman Instruments, 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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