OPIATES MICRO-PLATE ASSAY— 510(k) K935565
Substantially EquivalentSolarcare Technologies Corp,Inc.
FDA 510(k) clearance K935565 for OPIATES MICRO-PLATE ASSAY, Substantially Equivalent on 1995-07-14. Applicant: Solarcare Technologies Corp,Inc.. Device class: 2.
Clearance details
- Applicant
- Solarcare Technologies Corp,Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
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