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FDA 510(k)

RUBELLA ANTIBODY FLUOROIMMUNOASSAY

K-Number: K841174 · 1984-06-07

ApplicantIntl. Diagnostic Technology
Decision Date1984-06-07
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA ANTIBODY FLUOROIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K841174. 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 ANTIBODY FLUOROIMMUNOASSAY?

RUBELLA ANTIBODY FLUOROIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K841174.

When did RUBELLA ANTIBODY FLUOROIMMUNOASSAY receive FDA 510(k) clearance?

RUBELLA ANTIBODY FLUOROIMMUNOASSAY received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841174.

Who is the listed applicant for RUBELLA ANTIBODY FLUOROIMMUNOASSAY?

The FDA 510(k) record lists Intl. Diagnostic Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBELLA ANTIBODY FLUOROIMMUNOASSAY?

The FDA product code for RUBELLA ANTIBODY FLUOROIMMUNOASSAY is GOL.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN 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.

K834032RUBAQUICK 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.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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