STATSPIN MINI-PLASMA— 510(k) K893613

Substantially Equivalent

Statspin Technologies

FDA 510(k) clearance K893613 for STATSPIN MINI-PLASMA, Substantially Equivalent on 1989-08-28. Applicant: Statspin Technologies.

Clearance details

Applicant: Statspin Technologies
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1989-05-10
Decision date: 1989-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

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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.