NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040— 510(k) K033302

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K033302 for NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040, Substantially Equivalent on 2004-01-26. Applicant: Nichols Institute Diagnostics.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2003-10-14
Decision date: 2004-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Clemente, CA, 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.