ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P— 510(k) K972721
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K972721 for ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P, Substantially Equivalent on 1997-08-06. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.