Cleared Traditional

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

K222439 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Aug 2023
Decision
361d
Days
Class 2
Risk

About This 510(k) Submission

K222439 is an FDA 510(k) clearance for the Atellica? CH Phencyclidine (Pcp), Atellica? CH Vancomycin (Vanc), a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on August 8, 2023, 361 days after receiving the submission on August 12, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K222439 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2022
Decision Date August 08, 2023
Days to Decision 361 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

Similar Devices — LEH Radioimmunoassay, Vancomycin

All 30
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · Siemens Healthcare Diagnostics, Inc. · Apr 2016
ONLINE TDM Vancomycin Gen.3
K152245 · Roche Diagnostics Operations (Rdo) · Jan 2016
ARCHITECT IVANCOMYCIN
K123947 · Biokit, S.A. · Aug 2013
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
K072036 · Biokit, S.A. · Mar 2008
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · Diagnostic Products Corp. · Dec 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · Roche Diagnostics Corp. · May 2006