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FDA 510(k)

RUBELLA ANTIBODIES TEST REAGENTS

K-Number: K810309 · 1981-03-11

ApplicantCalbiochem-Behring Corp.
Decision Date1981-03-11
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA ANTIBODIES TEST REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810309. 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 ANTIBODIES TEST REAGENTS?

RUBELLA ANTIBODIES TEST REAGENTS is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K810309.

When did RUBELLA ANTIBODIES TEST REAGENTS receive FDA 510(k) clearance?

RUBELLA ANTIBODIES TEST REAGENTS received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810309.

Who is the listed applicant for RUBELLA ANTIBODIES TEST REAGENTS?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBELLA ANTIBODIES TEST REAGENTS?

The FDA product code for RUBELLA ANTIBODIES TEST REAGENTS is GOL.

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Other records listing Calbiochem-Behring Corp. 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.

K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEK831036ENA TEST KIT SM & RNP AUTO ANTIBODYK830214AFT SYSTEM IIIK820812CREATINE KINASE-MB KITK813493ENZYGNOST TM RUBELLA IGMK820088AFT SYSTEM PROFICIENCY TESTING PROGRAM

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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 LaboratoriesK802508RUBELISA 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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