S-MONOVETTE EDTA K2-GEL— 510(k) K031359

Substantially Equivalent

Sarstedt, Inc.

FDA 510(k) clearance K031359 for S-MONOVETTE EDTA K2-GEL, Substantially Equivalent on 2003-09-12. Applicant: Sarstedt, Inc..

Clearance details

Applicant: Sarstedt, Inc.
Product code: Code PJE
Advisory panel: Clinical Chemistry
Date received: 2003-04-30
Decision date: 2003-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, NC, US

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Adverse events under product code PJE

product code PJE

Malfunction: 540
Total: 540

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.