LEVEL II CONTROL SERUM— 510(k) K821558

Substantially Equivalent

Irvine Scientific

FDA 510(k) clearance K821558 for LEVEL II CONTROL SERUM, Substantially Equivalent on 1982-07-02. Applicant: Irvine Scientific.

Clearance details

Applicant: Irvine Scientific
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1982-05-25
Decision date: 1982-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.