Glucometer II Improved Reflectance Photometer
FDA 510(k) K861303 · Miles Laboratories, Inc.
510(k) numberK861303
Submission
- Device name
- Glucometer II Improved Reflectance Photometer
- Applicant
- Miles Laboratories, Inc.
Elkhart, IN, US - Received
- April 7, 1986
- Decision date
- July 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Glucometer II Improved Reflectance Photometer cleared by the FDA?
Glucometer II Improved Reflectance Photometer (K861303) received a 510(k) decision of Substantially Equivalent on July 2, 1986, 86 days after the submission was received.
What is the product code of K861303?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.