On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System— 510(k) K181527
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K181527 for On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System, Substantially Equivalent on 2018-10-03. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from ACON Laboratories, Inc.
view allAdverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.