LYRIS MODULAR INFO SYSTEM— 510(k) K831830

Substantially Equivalent

Biovation, Inc.

FDA 510(k) clearance K831830 for LYRIS MODULAR INFO SYSTEM, Substantially Equivalent on 1984-06-25. Applicant: Biovation, Inc..

Clearance details

Applicant
Biovation, Inc.
Product code
Code JQP
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JQP

product code JQP
Death
3
Malfunction
690
Total
693

Source: openFDA MAUDE database, through . 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.