Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)— 510(k) K160202

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K160202 for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL), Substantially Equivalent on 2016-04-27. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code LEH
Device class
Class 2
Regulation
21 CFR 862.3950
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
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