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FDA 510(k)

RUBAQUICK DIAGNOSTIC KIT

K-Number: K834032 · 1984-04-17

ApplicantAbbott Laboratories
Decision Date1984-04-17
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBAQUICK DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K834032. 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 RUBAQUICK DIAGNOSTIC KIT?

RUBAQUICK DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Abbott Laboratories. The 510(k) number is K834032.

When did RUBAQUICK DIAGNOSTIC KIT receive FDA 510(k) clearance?

RUBAQUICK DIAGNOSTIC KIT received FDA 510(k) clearance on 1984-04-17, under 510(k) number K834032.

Who is the listed applicant for RUBAQUICK DIAGNOSTIC KIT?

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 RUBAQUICK DIAGNOSTIC KIT?

The FDA product code for RUBAQUICK DIAGNOSTIC KIT 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 TechnologyK810309RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.K802508RUBELISA IGM TEST KITM.A. BioproductsK802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.K802339EIA RUBELLA-GBeckman Instruments, Inc.K801667GAMMA COAT(125 I) RUBELLA ANTIBODYClinical Assays, 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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