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FDA 510(k)

FIAX TEST KIT FOR GENTAMICIN QUAN.

K-Number: K800032 · 1980-01-23

ApplicantIntl. Diagnostic Technology
Decision Date1980-01-23
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR GENTAMICIN QUAN. 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 1980-01-23 under 510(k) number K800032. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX TEST KIT FOR GENTAMICIN QUAN.?

FIAX TEST KIT FOR GENTAMICIN QUAN. is a medical device that received FDA 510(k) clearance on 1980-01-23. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K800032.

When did FIAX TEST KIT FOR GENTAMICIN QUAN. receive FDA 510(k) clearance?

FIAX TEST KIT FOR GENTAMICIN QUAN. received FDA 510(k) clearance on 1980-01-23, under 510(k) number K800032.

Who is the listed applicant for FIAX TEST KIT FOR GENTAMICIN QUAN.?

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 FIAX TEST KIT FOR GENTAMICIN QUAN.?

The FDA product code for FIAX TEST KIT FOR GENTAMICIN QUAN. is LCQ.

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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: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott Laboratories

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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