SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K141351
Substantially EquivalentBiotest Medical Corp.
FDA 510(k) clearance K141351 for SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2015-05-19. 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
- Traditional
- Location
- Taichung, TW
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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
- 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.