ACCU-CHEK Performa Blood Glucose Monitoring System— 510(k) K133741
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K133741 for ACCU-CHEK Performa Blood Glucose Monitoring System, Substantially Equivalent on 2014-08-29. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- 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
- Indianapolis, IN, US
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- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
More clearances from Roche Diagnostics
view allAdverse 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 →
Recalls naming K133741
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133741.
Data sourced from openFDA. This site is unofficial and independent of the FDA.