BIOCHECK TESTOSTERONE EIA, MODEL BC-1115— 510(k) K002294
Substantially EquivalentBiocheck, Inc.
FDA 510(k) clearance K002294 for BIOCHECK TESTOSTERONE EIA, MODEL BC-1115, Substantially Equivalent on 2000-10-02. Applicant: Biocheck, Inc.. Device class: 1.
Clearance details
- Applicant
- Biocheck, 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
- Northridge, CA, US
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