CARBAMAZEPINE EIA TEST— 510(k) K955100
Substantially EquivalentDiagnostic Reagents, Inc.
FDA 510(k) clearance K955100 for CARBAMAZEPINE EIA TEST, Substantially Equivalent on 1995-12-13. Applicant: Diagnostic Reagents, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Reagents, Inc.
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code KLT
view allMore clearances from Diagnostic Reagents, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.