ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE— 510(k) K043175
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K043175 for ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE, Substantially Equivalent on 2004-11-24. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code NHG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NHG
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