DeviceClearance

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

Substantially Equivalent

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

FDA 510(k) clearance K220977 for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer, Substantially Equivalent on 2023-07-20. Applicant: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Product code
Code JGS
Device class
Class 2
Regulation
21 CFR 862.1665
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Suzhou, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K220977

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220977.

Data sourced from openFDA. This site is unofficial and independent of the FDA.