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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K933464
Device Name STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
Applicant
Baxter Diagnostics, Inc.
Scientific Products Div.
1430 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact BETTY HERNANDEZ-LABADIE
Correspondent
Baxter Diagnostics, Inc.
Scientific Products Div.
1430 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact BETTY HERNANDEZ-LABADIE
Regulation Number862.1260
Classification Product Code
CHP  
Date Received07/16/1993
Decision Date 10/22/1993
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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