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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometeric, Protein Fractionation
510(k) Number K901463
Device Name REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact ERIC PETERSEN
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact ERIC PETERSEN
Regulation Number862.1630
Classification Product Code
JQJ  
Date Received03/28/1990
Decision Date 06/12/1990
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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