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FDA 510(k)

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

K-Number: K802102 · 1980-12-18

ApplicantCalbiochem-Behring Corp.
Decision Date1980-12-18
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI 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 1980-12-18 under 510(k) number K802102. 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 ELISA REAGENTS RUBELLA IGG ANTI?

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K802102.

When did RUBELLA ELISA REAGENTS RUBELLA IGG ANTI receive FDA 510(k) clearance?

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802102.

Who is the listed applicant for RUBELLA ELISA REAGENTS RUBELLA IGG ANTI?

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 ELISA REAGENTS RUBELLA IGG ANTI?

The FDA product code for RUBELLA ELISA REAGENTS RUBELLA IGG ANTI is GOL.

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Other records listing Calbiochem-Behring Corp. as applicant

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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 LaboratoriesK810309RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.K802508RUBELISA IGM TEST KITM.A. BioproductsK802339EIA 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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