Cleared Traditional

K861779 - GLUCOFACTS DATA PRINTER
(FDA 510(k) Clearance)

K861779 · Miles Laboratories, Inc. · Chemistry

Aug 1986

Decision

92d

Days

Class 1

Risk

K861779 is an FDA 510(k) clearance for the GLUCOFACTS DATA PRINTER. This device is classified as 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 8, 1986, 92 days after receiving the submission on May 8, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number	K861779 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1986
Decision Date	August 08, 1986
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—