CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3— 510(k) K932658

Substantially Equivalent

More Diagnostics

FDA 510(k) clearance K932658 for CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3, Substantially Equivalent on 1993-07-28. Applicant: More Diagnostics.

Clearance details

Applicant: More Diagnostics
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1993-06-02
Decision date: 1993-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Osos, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.