Cleared Traditional

K220977 - ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (FDA 510(k) Clearance)

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

Jul 2023

Decision

472d

Days

Class 2

Risk

K220977 is an FDA 510(k) clearance for the ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K220977 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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