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FDA 510(k)

COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA

K-Number: K843828 · 1985-02-01

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-02-01
Product CodeLFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K843828. The device is classified under product code LFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA?

COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K843828.

When did COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA receive FDA 510(k) clearance?

COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA received FDA 510(k) clearance on 1985-02-01, under 510(k) number K843828.

Who is the listed applicant for COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA?

The FDA product code for COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA is LFW.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: LFW)

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.

K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.K944371TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORSigma Diagnostics, Inc.K941614AXSYM TOBRAMYCINAbbott LaboratoriesK912143CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp.K900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.K894531FPR TOBRAMYCIN KITColony Laboratories, 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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