Easygluco IGM-0002 G2
FDA 510(k) K043512 · American Healthcare, Inc.
510(k) numberK043512
Submission
- Device name
- Easygluco IGM-0002 G2
- Applicant
- American Healthcare, Inc.
New York, NY, US - Received
- December 20, 2004
- Decision date
- April 8, 2005
- 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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| K031501 | Easygluco, Model IGM0002NBW · Traditional | 10/16/2003SE |
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Questions and answers
When was Easygluco IGM-0002 G2 cleared by the FDA?
Easygluco IGM-0002 G2 (K043512) received a 510(k) decision of Substantially Equivalent on April 8, 2005, 109 days after the submission was received.
What is the product code of K043512?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.