ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K092104
Substantially EquivalentArkray Factory USA, Inc.
FDA 510(k) clearance K092104 for ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2009-11-24. Applicant: Arkray Factory USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray Factory USA, 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
- Edina, MN, US
Recent devices under product code CGA
view allMore clearances from Arkray Factory USA, Inc.
view all- K110709 — ARK CARE DIABETES MANAGMENT SYSTEM
- K093819 — ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
- K091102 — ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
- K090653 — POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
- K090332 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
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.