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FDA 510(k)

GAMMA COAT(125 I) RUBELLA ANTIBODY

K-Number: K801667 · 1980-10-23

ApplicantClinical Assays, Inc.
Decision Date1980-10-23
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GAMMA COAT(125 I) RUBELLA ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801667. 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 GAMMA COAT(125 I) RUBELLA ANTIBODY?

GAMMA COAT(125 I) RUBELLA ANTIBODY is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K801667.

When did GAMMA COAT(125 I) RUBELLA ANTIBODY receive FDA 510(k) clearance?

GAMMA COAT(125 I) RUBELLA ANTIBODY received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801667.

Who is the listed applicant for GAMMA COAT(125 I) RUBELLA ANTIBODY?

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

What is the FDA product code for GAMMA COAT(125 I) RUBELLA ANTIBODY?

The FDA product code for GAMMA COAT(125 I) RUBELLA ANTIBODY is GOL.

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Other records listing Clinical Assays, 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.

K832711VITAMIN B12 FOLATE CA-1515-125K832712FOLATE RADIOASSAY KIT CA-1562-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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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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