TRI-LEVEL BILIRUBIN CONTROLS— 510(k) K833898
Substantially EquivalentSandare Chemical Co., Inc.
FDA 510(k) clearance K833898 for TRI-LEVEL BILIRUBIN CONTROLS, Substantially Equivalent on 1984-01-13. Applicant: Sandare Chemical Co., Inc..
Clearance details
- Applicant
- Sandare Chemical Co., Inc.
- 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.