DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM— 510(k) K100806
Substantially EquivalentDelbio Incorporation
FDA 510(k) clearance K100806 for DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM, Substantially Equivalent on 2011-09-16. Applicant: Delbio Incorporation. Device class: 2.
Clearance details
- Applicant
- Delbio Incorporation
- 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
- Taoyuan, TW
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More clearances from Delbio Incorporation
view all- K133090 — OXICARE FINGERTIP PULSE OXIMETER
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- K130244 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K120866 — DA01 BLOOD GLUCOSE MONITORING SYSTEM
- K103329 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
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.