LEECO PRL-QUANT DIAGNOSTIC TEST KIT— 510(k) K820039
Substantially EquivalentLeeco Diagnostics, Inc.
FDA 510(k) clearance K820039 for LEECO PRL-QUANT DIAGNOSTIC TEST KIT, Substantially Equivalent on 1982-01-22. Applicant: Leeco Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Leeco Diagnostics, Inc.
- Product code
- Code CFT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1625
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code CFT
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