SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268— 510(k) K091815
Substantially EquivalentBiotest Medical Corp.
FDA 510(k) clearance K091815 for SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268, Substantially Equivalent on 2009-11-16. Applicant: Biotest Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Biotest Medical Corp.
- 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
- Fairfax, VA, US
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More clearances from Biotest Medical Corp.
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- K122525 — SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K100560 — EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
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.