EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO— 510(k) K133509
Substantially EquivalentBiotest Medical Corp.
FDA 510(k) clearance K133509 for EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO, Substantially Equivalent on 2014-02-21. Applicant: Biotest Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Biotest Medical Corp.
- 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
- Special
- Location
- Eatontown, NJ, US
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More clearances from Biotest Medical Corp.
view all- K141351 — SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K123559 — SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
- K122525 — SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K100560 — EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
- K100701 — SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM 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.