Tracker System

FDA 510(k) K860948 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK860948

Submission

Device name
Tracker System
Applicant
Boehringer Mannheim Corp.
Indianapolis, IN, US
Received
March 12, 1986
Decision date
December 8, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CGA – Glucose Oxidase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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Questions and answers

When was Tracker System cleared by the FDA?

Tracker System (K860948) received a 510(k) decision of Substantially Equivalent on December 8, 1986, 271 days after the submission was received.

What is the product code of K860948?

The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.