Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product)
FDA 510(k) K022158 · Instrumentation Laboratory CO
510(k) numberK022158
Submission
- Device name
- Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product)
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- July 2, 2002
- Decision date
- September 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product) cleared by the FDA?
Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration Validation Product) (K022158) received a 510(k) decision of Substantially Equivalent on September 10, 2002, 70 days after the submission was received.
What is the product code of K022158?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.