DeviceClearance

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer— 510(k) K221225

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K221225 for Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, Substantially Equivalent on 2022-11-10. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code JLW
Device class
Class 2
Regulation
21 CFR 862.1690
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JLW

view all

More clearances from Beckman Coulter, Inc.

view all

Adverse events under product code JLW

product code JLW
Malfunction
885
Total
885

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 K221225

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 K221225.

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