COAGUCHEK XS SYSTEM— 510(k) K060978
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K060978 for COAGUCHEK XS SYSTEM, Substantially Equivalent on 2006-08-11. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- 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
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 K060978
K-number listed on FDA's recall record- Z-0803-2021 — CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001
- Z-1584-2013 — CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060978.
Data sourced from openFDA. This site is unofficial and independent of the FDA.