K973448

Substantially Equivalent

ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469

Applicant: Beckman Instruments, Inc.
Product code: LGD
Advisory panel: Microbiology
Date received: 1997-09-11
Decision date: 1998-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

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.