Home / 510(k) Clearances / K060585

510(k) K060585

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH by Roche Diagnostics Corp. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2006
Date Received
March 7, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Acth
Device Class
Class II
Regulation Number
862.1025
Review Panel
CH
Submission Type

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  • K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (June 3, 2002)
  • K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (January 17, 2001)
  • K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (August 19, 1998)
  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960491 — MICRO HAEMATOCRIT CENTRIFUGE (October 18, 1996)
  • K960066 — IMMULITE ACTH (February 16, 1996)
  • K940271 — INCSTAR ACTH IRMA (August 2, 1994)