FDA 510(k)

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

K-번호: K160202 · 2016-04-27

결정일2016-04-27

제품 코드LEH

자문 위원회TX

결정Substantially Equivalent

기기 요약

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-04-27 under 510(k) number K160202. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K160202.

When did Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) receive FDA 510(k) clearance?

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

Who is the listed applicant for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Siemens Healthcare Diagnostics, Inc.를 신청인으로 등재한 기타 기록

K253528아테리카 IM CA 19-9 II K261364아테리카 CH 아세트아미노펜 2 (ACTM)K251998Atellica CH 디아조 전체 빌리루빈 (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630아테리카 IM 전체 PSA II (tPSAII)K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)

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