Cleared Traditional

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

K220977 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Chemistry

Jul 2023

Decision

472d

Days

Class 2

Risk

About This 510(k) Submission

K220977 is an FDA 510(k) clearance for the ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 20, 2023, 472 days after receiving the submission on April 4, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K220977 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2022
Decision Date	July 20, 2023
Days to Decision	472 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF