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510(k) K982608

SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT by Sangui Biotech, Inc. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1998
Date Received
July 27, 1998
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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