On Call Express Pro Blood Glucose Monitoring System— 510(k) K151595
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K151595 for On Call Express Pro Blood Glucose Monitoring System, Substantially Equivalent on 2015-09-05. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Product 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 all- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
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- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
Adverse 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.