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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K945353
Device Name CLARIT(TM)
Applicant
Advanced Biomedical Methods, Inc.
P.O. Box 48026
Niles,  IL  60648
Applicant Contact JACK M GOLDBERG
Correspondent
Advanced Biomedical Methods, Inc.
P.O. Box 48026
Niles,  IL  60648
Correspondent Contact JACK M GOLDBERG
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
JQC  
Date Received10/20/1994
Decision Date 12/09/1994
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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