Stat Chem System

FDA 510(k) K891050 · Diagnostic Resources, Inc.

Substantially Equivalent

510(k) numberK891050

Submission

Device name
Stat Chem System
Applicant
Diagnostic Resources, Inc.
Bohemia, NY, US
Received
February 28, 1989
Decision date
July 20, 1989
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 Stat Chem System cleared by the FDA?

Stat Chem System (K891050) received a 510(k) decision of Substantially Equivalent on July 20, 1989, 142 days after the submission was received.

What is the product code of K891050?

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