Biovation Max Data Management System
by Biovation, Inc. 510(k)
Active
510(k) K853026
Overview
The BIOVATION MAX DATA MANAGEMENT SYSTEM is a comprehensive calculator/data processing module designed for clinical use. Developed by Biovation, Inc., it provides accurate and reliable data management capabilities for laboratory testing and analysis.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853026 | Date2 Aug 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JQP
- Device Class
- Class I
- Regulation
- 21 CFR Part 862.2100
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent