Accu-Chek FastClix Blood Lancing System— 510(k) K220608
Substantially EquivalentRoche Diabetes Care, Inc.
FDA 510(k) clearance K220608 for Accu-Chek FastClix Blood Lancing System, Substantially Equivalent on 2022-04-29. Applicant: Roche Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diabetes Care, Inc.
- Product code
- Code QRL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code QRL
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view allAdverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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