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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrolyte Controls (Assayed And Unassayed)
510(k) Number K951435
Device Name AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
Applicant
Aalto Scientific, Ltd.
1160 Joshua Way
Vista,  CA  92083
Applicant Contact KEVIN JONES
Correspondent
Aalto Scientific, Ltd.
1160 Joshua Way
Vista,  CA  92083
Correspondent Contact KEVIN JONES
Regulation Number862.1660
Classification Product Code
JJR  
Date Received03/27/1995
Decision Date 05/02/1995
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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