BIOVATION MAX DATA MANAGEMENT SYSTEM— 510(k) K853026

Substantially Equivalent

Biovation, Inc.

FDA 510(k) clearance K853026 for BIOVATION MAX DATA MANAGEMENT SYSTEM, Substantially Equivalent on 1985-08-02. Applicant: Biovation, Inc..

Clearance details

Applicant: Biovation, Inc.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1985-07-18
Decision date: 1985-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Pablo, CA, 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.