510(k) K940221

ACCESS CORTISOL REAGENTS by Bio-Rad Laboratories, Inc. — Product Code CGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
January 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
Review Panel
CH
Submission Type