LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY— 510(k) K903130

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K903130 for LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY, Substantially Equivalent on 1990-09-25. Applicant: London Diagnostics, Inc..

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1990-07-17
Decision date: 1990-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.