Accu-Check Combo System
FDA 510(k) K111353 · Roche Diagnostics
510(k) numberK111353
Submission
- Device name
- Accu-Check Combo System
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- May 16, 2011
- Decision date
- July 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Accu-Check Combo System cleared by the FDA?
Accu-Check Combo System (K111353) received a 510(k) decision of Substantially Equivalent on July 17, 2012, 428 days after the submission was received.
What is the product code of K111353?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.