ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469— 510(k) K973448

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K973448 for ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469, Substantially Equivalent on 1998-09-17. Applicant: Beckman Instruments, Inc..

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: 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

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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.