TESTOTERONE ELISA— 510(k) K973900
Substantially EquivalentKmi Diagnostics, Inc.
FDA 510(k) clearance K973900 for TESTOTERONE ELISA, Substantially Equivalent on 1998-02-24. Applicant: Kmi Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Kmi Diagnostics, 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
- Minneapolis, MN, US
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