PRECINORM U & PRECIPATH U HUMAN SERUM— 510(k) K811832
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K811832 for PRECINORM U & PRECIPATH U HUMAN SERUM, Substantially Equivalent on 1981-07-15. Applicant: Boehringer Mannheim Corp..
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, 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.