Cleared Traditional

K861844 - GLUCOFACTS DATA MANAGEMENT SYSTEM
(FDA 510(k) Clearance)

K861844 · Miles Laboratories, Inc. · Chemistry

Aug 1986

Decision

91d

Days

Class 1

Risk

K861844 is an FDA 510(k) clearance for the GLUCOFACTS 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 August 12, 1986, 91 days after receiving the submission on May 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number	K861844 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 1986
Decision Date	August 12, 1986
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—