SMARTCHECK INR SYSTEM— 510(k) K071265
Substantially EquivalentInverness Medical Innovations, Inc.
FDA 510(k) clearance K071265 for SMARTCHECK INR SYSTEM, Substantially Equivalent on 2007-11-30. Applicant: Inverness Medical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Inverness Medical Innovations, Inc.
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code JPA
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- K011479 — ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K011616 — INDUO BLOOD GLUCOSE METER
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.