LEECO T4 QUANT DIAGNOSTICS TEST KIT— 510(k) K822399
Substantially EquivalentLeeco Diagnostics, Inc.
FDA 510(k) clearance K822399 for LEECO T4 QUANT DIAGNOSTICS TEST KIT, Substantially Equivalent on 1982-09-13. Applicant: Leeco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Leeco Diagnostics, Inc.
- Product code
- Code CDX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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