Cleared Traditional

CLINIFACTS 200 DATA MANAGEMENT SYSTEM

K861778 · Miles Laboratories, Inc. · Chemistry
Jul 1986
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K861778 is an FDA 510(k) clearance for the CLINIFACTS 200 DATA MANAGEMENT SYSTEM, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on July 2, 1986, 55 days after receiving the submission on May 8, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K861778 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1986
Decision Date July 02, 1986
Days to Decision 55 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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