ACCU-CHEK AVIVA PLUS TEST STRIP— 510(k) K131029
Substantially EquivalentRoche Diagnostics Operations, Inc.
FDA 510(k) clearance K131029 for ACCU-CHEK AVIVA PLUS TEST STRIP, Substantially Equivalent on 2013-08-09. Applicant: Roche Diagnostics Operations, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations, Inc.
- 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
- Special
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Operations, Inc.
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 K131029
K-number listed on FDA's recall record- Z-2351-2021 — Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
- Z-0997-2020 — Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
- Z-0998-2020 — Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
- Z-2185-2018 — Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
- Z-2186-2018 — Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
- Z-2187-2018 — Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131029.
Data sourced from openFDA. This site is unofficial and independent of the FDA.