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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric, Cortisol
510(k) Number K931031
Device Name VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
Applicant
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact VICKI ANASTASI
Correspondent
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact VICKI ANASTASI
Regulation Number862.1205
Classification Product Code
JFT  
Date Received03/01/1993
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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