Ultrachem E-Glu

FDA 510(k) K821868 · Harleco Diagnostics

Substantially Equivalent

510(k) numberK821868

Submission

Device name
Ultrachem E-Glu
Applicant
Harleco Diagnostics
Mchenry, IL, US
Received
June 25, 1982
Decision date
July 8, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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Questions and answers

When was Ultrachem E-Glu cleared by the FDA?

Ultrachem E-Glu (K821868) received a 510(k) decision of Substantially Equivalent on July 8, 1982, 13 days after the submission was received.

What is the product code of K821868?

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