ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH— 510(k) K051646

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K051646 for ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH, Substantially Equivalent on 2005-10-07. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2005-06-21
Decision date: 2005-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.