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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Digoxin
510(k) Number K934003
Device Name STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
Applicant
Baxter Diagnostics, Inc.
Scientific Products Div.
1430 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact RONALD H LENTSCH
Correspondent
Baxter Diagnostics, Inc.
Scientific Products Div.
1430 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact RONALD H LENTSCH
Regulation Number862.3320
Classification Product Code
DKA  
Date Received08/17/1993
Decision Date 11/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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