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FDA 510(k)

CYBREX GENTAMICIN

K-Number: K801084 · 1980-05-23

ApplicantAbbott Laboratories
Decision Date1980-05-23
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CYBREX GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K801084. 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 CYBREX GENTAMICIN?

CYBREX GENTAMICIN is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Abbott Laboratories. The 510(k) number is K801084.

When did CYBREX GENTAMICIN receive FDA 510(k) clearance?

CYBREX GENTAMICIN received FDA 510(k) clearance on 1980-05-23, under 510(k) number K801084.

Who is the listed applicant for CYBREX GENTAMICIN?

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

What is the FDA product code for CYBREX GENTAMICIN?

The FDA product code for CYBREX GENTAMICIN is LCQ.

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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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