MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002— 510(k) K060420

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K060420 for MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002, Substantially Equivalent on 2006-03-01. Applicant: Scantibodies Laboratory, Inc..

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2006-02-17
Decision date: 2006-03-01
Decision: Substantially Equivalent
Clearance type: Special
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.