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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Carbamazepine
510(k) Number K873282
Device Name CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
Applicant
Windsor Laboratories, Inc.
P.O. Box 475487
Garland,  TX  75047
Applicant Contact GUY W RUCKER
Correspondent
Windsor Laboratories, Inc.
P.O. Box 475487
Garland,  TX  75047
Correspondent Contact GUY W RUCKER
Regulation Number862.3645
Classification Product Code
KLT  
Date Received08/17/1987
Decision Date 09/22/1987
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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