TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600— 510(k) K004038

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K004038 for TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600, Substantially Equivalent on 2001-04-30. Applicant: Scantibodies Laboratory, Inc..

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2000-12-28
Decision date: 2001-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santee, 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.