RIGHT-DAY URINARY LH (EIA)— 510(k) K860538
Substantially EquivalentLeeco Diagnostics, Inc.
FDA 510(k) clearance K860538 for RIGHT-DAY URINARY LH (EIA), Substantially Equivalent on 1986-07-29. Applicant: Leeco Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Leeco Diagnostics, Inc.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southfield, MI, US
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