QUICK SAMPLER HOLDER— 510(k) K120490

Substantially Equivalent

Nipro Medical Corporation

FDA 510(k) clearance K120490 for QUICK SAMPLER HOLDER, Substantially Equivalent on 2012-12-27. Applicant: Nipro Medical Corporation.

Clearance details

Applicant: Nipro Medical Corporation
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2012-02-17
Decision date: 2012-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.