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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K871486
Device Name (FPIA) ASSAY BUFFER
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 Number862.2170
Classification Product Code
JJF  
Date Received04/15/1987
Decision Date 05/08/1987
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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