Cleared Traditional

BIOVATION MAX DATA MANAGEMENT SYSTEM

K853026 · Biovation, Inc. · Chemistry
Aug 1985
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K853026 is an FDA 510(k) clearance for the BIOVATION MAX DATA MANAGEMENT SYSTEM, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Biovation, Inc. (San Pablo, US). The FDA issued a Cleared decision on August 2, 1985, 15 days after receiving the submission on July 18, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K853026 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1985
Decision Date August 02, 1985
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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