Total CO2

FDA 510(k) K951221 · Randox Laboratories, Ltd.

Substantially Equivalent

510(k) numberK951221

Submission

Device name
Total CO2
Applicant
Randox Laboratories, Ltd.
Antrim, N. Ireland, IR
Received
March 20, 1995
Decision date
February 15, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KHS – Enzymatic, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Specialty
Clinical Chemistry

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Questions and answers

When was Total CO2 cleared by the FDA?

Total CO2 (K951221) received a 510(k) decision of Substantially Equivalent on February 15, 1996, 332 days after the submission was received.

What is the product code of K951221?

The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.