Cleared Traditional

K860948 - TRACKER SYSTEM (FDA 510(k) Clearance)

K860948 · Boehringer Mannheim Corp. · Chemistry device
Dec 1986
Decision
271d
Days
Class 2
Risk

K860948 is an FDA 510(k) clearance for the TRACKER SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 8, 1986, 271 days after receiving the submission on March 12, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K860948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1986
Decision Date December 08, 1986
Days to Decision 271 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1345