WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056— 510(k) K001411

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K001411 for WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056, Substantially Equivalent on 2000-08-21. Applicant: Scantibodies Laboratory, Inc..

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2000-05-04
Decision date: 2000-08-21
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.