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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K940221
Device Name ACCESS CORTISOL REAGENTS
Applicant
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact JAN OLSEN
Correspondent
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact JAN OLSEN
Regulation Number862.1205
Classification Product Code
CGR  
Date Received01/18/1994
Decision Date 04/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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