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FDA 510(k)

RUBELISA IGM TEST KIT

K-Number: K802508 · 1980-12-18

ApplicantM.A. Bioproducts
Decision Date1980-12-18
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELISA IGM TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802508. 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 RUBELISA IGM TEST KIT?

RUBELISA IGM TEST KIT is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is M.A. Bioproducts. The 510(k) number is K802508.

When did RUBELISA IGM TEST KIT receive FDA 510(k) clearance?

RUBELISA IGM TEST KIT received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802508.

Who is the listed applicant for RUBELISA IGM TEST KIT?

The FDA 510(k) record lists M.A. Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBELISA IGM TEST KIT?

The FDA product code for RUBELISA IGM TEST KIT is GOL.

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Other records listing M.A. Bioproducts 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.

K822883HERPELISA KITK823804MYCOPLASMELISA TEST KITK830045MUMPSELISA TEST KITK830615CYTOMEGELISA STATK823805VARICELISA TEST KITK821967CHLAMYDELISA TEST 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.K802102RUBELLA 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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