ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K111371
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K111371 for ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2011-10-06. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code CGA
- 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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Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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.