ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH— 510(k) K060585
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K060585 for ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH, Substantially Equivalent on 2006-05-03. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code CKG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1025
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CKG
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