COAGUCHEK XS SYSTEM— 510(k) K062925
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K062925 for COAGUCHEK XS SYSTEM, Substantially Equivalent on 2007-01-29. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code GJS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code GJS
view allMore clearances from Roche Diagnostics Corp.
view allAdverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
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 K062925
K-number listed on FDA's recall record- Z-0804-2021 — CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
- Z-1581-2013 — CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062925.
Data sourced from openFDA. This site is unofficial and independent of the FDA.