Cleared Traditional

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

K201256 · Procise Diagnostics · Immunology

Nov 2022

Decision

907d

Days

Class 2

Risk

About This 510(k) Submission

K201256 is an FDA 510(k) clearance for the Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Procise Diagnostics (San Diego, US). The FDA issued a Cleared decision on November 4, 2022, 907 days after receiving the submission on May 11, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K201256 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2020
Decision Date	November 04, 2022
Days to Decision	907 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF