PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404— 510(k) K020831
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K020831 for PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404, Substantially Equivalent on 2002-10-24. Applicant: Roche Diagnostics Corp..
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code GJS
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.