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FDA 510(k), K060585, ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
FDA 510(k), K060585, ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
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510(K) Number: K060585
Device Name: ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: radioimmunoassay, acth
Regulation Number: 862.1025
Classification Product Code: CKG
Date Received: 03/07/2006
Decision Date: 05/03/2006
Regulation Medical Specialty: Clinical Chemistry
Device Name: ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: radioimmunoassay, acth
Regulation Number: 862.1025
Classification Product Code: CKG
Date Received: 03/07/2006
Decision Date: 05/03/2006
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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