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FDA 510(k)

ONLINE TDM TOBRAMYCIN

K-Number: K060853 · 2006-06-09

ApplicantRoche Diagnostics Corp.
Decision Date2006-06-09
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE TDM TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K060853. The device is classified under product code KLB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE TDM TOBRAMYCIN?

ONLINE TDM TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K060853.

When did ONLINE TDM TOBRAMYCIN receive FDA 510(k) clearance?

ONLINE TDM TOBRAMYCIN received FDA 510(k) clearance on 2006-06-09, under 510(k) number K060853.

Who is the listed applicant for ONLINE TDM TOBRAMYCIN?

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

What is the FDA product code for ONLINE TDM TOBRAMYCIN?

The FDA product code for ONLINE TDM TOBRAMYCIN is KLB.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: KLB)

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.

K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)Diagnostic Products Corp.K003341EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.K904304DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHODE.I. Dupont DE Nemours & Co., Inc.K903192IL TOBRAMYCIN ASSAYInstrumentation Laboratory COK893913TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHODTechnicon Instruments Corp.K882294EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAYSyva Co.

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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