Blood Glucose Monitoring System (Glucose Oxidase)
FDA 510(k) K113636 · Philosys Co., Ltd.
510(k) numberK113636
Submission
- Device name
- Blood Glucose Monitoring System (Glucose Oxidase)
- Applicant
- Philosys Co., Ltd.
New York, NY, US - Received
- December 9, 2011
- Decision date
- March 8, 2013
- 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 Blood Glucose Monitoring System (Glucose Oxidase) cleared by the FDA?
Blood Glucose Monitoring System (Glucose Oxidase) (K113636) received a 510(k) decision of Substantially Equivalent on March 8, 2013, 455 days after the submission was received.
What is the product code of K113636?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.