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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K072141
Device Name S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Applicant Contact DAVID SLAVIN
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Correspondent Contact DAVID SLAVIN
Regulation Number862.1580
Classification Product Code
CEO  
Subsequent Product Code
KNK  
Date Received08/02/2007
Decision Date 06/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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