DeviceClearance

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100— 510(k) K023764

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K023764 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100, Substantially Equivalent on 2003-01-28. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code JJE
Device class
Class 1
Regulation
21 CFR 862.2160
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, US
Download summary PDFView on FDA.gov ↗

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More clearances from Beckman Coulter, Inc.

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Adverse events under product code JJE

product code JJE
Death
6
Injury
441
Malfunction
25,011
Other
1
Total
25,459

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 K023764

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 K023764.

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