GEM Premier ChemSTAT
FDA 510(k) K223090 · Instrumentation Laboratory CO
510(k) numberK223090
Submission
- Device name
- GEM Premier ChemSTAT
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- September 30, 2022
- Decision date
- January 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 GEM Premier ChemSTAT cleared by the FDA?
GEM Premier ChemSTAT (K223090) received a 510(k) decision of Substantially Equivalent on January 27, 2023, 119 days after the submission was received.
What is the product code of K223090?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.