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FDA 510(k)

ONLINE TDM Vancomycin Gen.3

K-Number: K152245 · 2016-01-08

ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2016-01-08
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE TDM Vancomycin Gen.3 is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-01-08 under approval number K152245. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE TDM Vancomycin Gen.3?

ONLINE TDM Vancomycin Gen.3 is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K152245.

When was ONLINE TDM Vancomycin Gen.3 approved by the FDA?

ONLINE TDM Vancomycin Gen.3 received FDA 510(k) clearance on 2016-01-08, under approval number K152245.

What company makes ONLINE TDM Vancomycin Gen.3?

ONLINE TDM Vancomycin Gen.3 is manufactured by Roche Diagnostics Operations (Rdo).

What is the FDA product code for ONLINE TDM Vancomycin Gen.3?

The FDA product code for ONLINE TDM Vancomycin Gen.3 is LEH.

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Related Devices (Code: LEH)

K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc. K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, 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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