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FDA 510(k)

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)

K-Number: K222439 · 2023-08-08

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-08-08
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-08-08 under approval number K222439. 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 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)?

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K222439.

When was Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) approved by the FDA?

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) received FDA 510(k) clearance on 2023-08-08, under approval number K222439.

What company makes Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)?

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)?

The FDA product code for Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) is LEH.

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Related Devices (Code: 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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