AUTOMATIC BIOCHEMICAL ANALYZER— 510(k) K810063

Substantially Equivalent

Acculab

FDA 510(k) clearance K810063 for AUTOMATIC BIOCHEMICAL ANALYZER, Substantially Equivalent on 1981-01-26. Applicant: Acculab.

Clearance details

Applicant: Acculab
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1981-01-13
Decision date: 1981-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.