ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER— 510(k) K973966

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K973966 for ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, Substantially Equivalent on 1997-10-31. Applicant: Beckman Instruments, Inc..

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1997-10-17
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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