510(k) K791740

SERUM 11-DESOXYCORTISOL I AS TRACER by Radioassay Systems Laboratories, Inc. — Product Code JKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1979
Date Received
September 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Compound S (11-Deoxycortisol)
Device Class
Class I
Regulation Number
862.1185
Review Panel
CH
Submission Type