ACCU-CHEK Connect Diabetes Management App
FDA 510(k) K150910 · Roche Diabetes Care, Inc.
510(k) numberK150910
Submission
- Device name
- ACCU-CHEK Connect Diabetes Management App
- Applicant
- Roche Diabetes Care, Inc.
Indianapolis, IN, US - Received
- April 3, 2015
- Decision date
- June 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K220608 | Accu-Chek FastClix Blood Lancing SystemQRL · Traditional | 04/29/2022SE |
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Questions and answers
When was ACCU-CHEK Connect Diabetes Management App cleared by the FDA?
ACCU-CHEK Connect Diabetes Management App (K150910) received a 510(k) decision of Substantially Equivalent on June 3, 2015, 61 days after the submission was received.
What is the product code of K150910?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.