WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002— 510(k) K051141

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K051141 for WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002, Substantially Equivalent on 2005-07-26. Applicant: Scantibodies Laboratory, Inc..

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2005-05-04
Decision date: 2005-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santee, CA, US

Download summary PDF View on FDA.gov ↗

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.