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FDA 510(k)

CYBREX TOBRAMYCIN

K-Number: K802668 · 1980-11-24

ApplicantAbbott Laboratories
Decision Date1980-11-24
Product CodeLCR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CYBREX TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1980-11-24 under 510(k) number K802668. The device is classified under product code LCR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYBREX TOBRAMYCIN?

CYBREX TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 1980-11-24. The listed applicant is Abbott Laboratories. The 510(k) number is K802668.

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

CYBREX TOBRAMYCIN received FDA 510(k) clearance on 1980-11-24, under 510(k) number K802668.

Who is the listed applicant for CYBREX TOBRAMYCIN?

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 TOBRAMYCIN?

The FDA product code for CYBREX TOBRAMYCIN is LCR.

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Related Devices (Code: LCR)

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.

K060998QMS TOBRAMYCINSeradyn, Inc.K974029ACS TOBRAMYCINChiron Diagnostics Corp.K962818TOBRAMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.K952568BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENTBeckman Instruments, Inc.K911940OPUS(R) TOBRAMYCINPb Diagnostic Systems, Inc.K911613VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4Exmoor Plastics , Ltd.

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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