TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)— 510(k) K014120
Substantially EquivalentDiagnostics Biochem Canada, Inc.
FDA 510(k) clearance K014120 for TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA), Substantially Equivalent on 2002-02-08. Applicant: Diagnostics Biochem Canada, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostics Biochem Canada, 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
- London, Ontario, CA
Recent devices under product code CDZ
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