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FDA 510(k)

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

K-Number: K160202 · 2016-04-27

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-04-27
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-04-27 under approval number K160202. 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 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is a medical device that received FDA 510(k) clearance on 2016-04-27. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K160202.

When was Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) approved by the FDA?

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) received FDA 510(k) clearance on 2016-04-27, under approval number K160202.

What company makes Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

The FDA product code for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is LEH.

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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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