DRG AURICA ELISA TESTOSTERONE KIT— 510(k) K000043
Substantially EquivalentDrg Intl., Inc.
FDA 510(k) clearance K000043 for DRG AURICA ELISA TESTOSTERONE KIT, Substantially Equivalent on 2000-04-17. Applicant: Drg Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Drg Intl., 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
- East Stroudsburg, PA, US
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