LEECO TESTOSTERONE DIAGNOSTIC KIT— 510(k) K860003
Substantially EquivalentLeeco Diagnostics, Inc.
FDA 510(k) clearance K860003 for LEECO TESTOSTERONE DIAGNOSTIC KIT, Substantially Equivalent on 1986-03-17. Applicant: Leeco Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Leeco Diagnostics, Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southfield, MI, US
Recent devices under product code CDZ
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