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FDA 510(k)

RUBA-NOST TEST KITS

K-Number: K771796 · 1977-10-18

ApplicantBehring Diagnostics, Inc.
Decision Date1977-10-18
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBA-NOST TEST KITS is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771796. 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 RUBA-NOST TEST KITS?

RUBA-NOST TEST KITS is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K771796.

When did RUBA-NOST TEST KITS receive FDA 510(k) clearance?

RUBA-NOST TEST KITS received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771796.

Who is the listed applicant for RUBA-NOST TEST KITS?

The FDA 510(k) record lists Behring Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBA-NOST TEST KITS?

The FDA product code for RUBA-NOST TEST KITS is GOL.

Other records listing Behring Diagnostics, Inc. 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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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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