CO2/CI Standards

FDA 510(k) K822289 · Gilford Diagnostics

Substantially Equivalent

510(k) numberK822289

Submission

Device name
CO2/CI Standards
Applicant
Gilford Diagnostics
Mchenry, IL, US
Received
August 2, 1982
Decision date
August 24, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIX – Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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Questions and answers

When was CO2/CI Standards cleared by the FDA?

CO2/CI Standards (K822289) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 22 days after the submission was received.

What is the product code of K822289?

The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.