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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K881214
Device Name IMMPULSE T, ASSAY REAGENTS
Applicant
Sclavo, Inc.
1240 Elko Dr.
Sunnyvale,  CA  94089
Applicant Contact MICHAEL BRINKLEY
Correspondent
Sclavo, Inc.
1240 Elko Dr.
Sunnyvale,  CA  94089
Correspondent Contact MICHAEL BRINKLEY
Regulation Number862.1710
Classification Product Code
CDP  
Date Received03/21/1988
Decision Date 05/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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