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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, C-Peptides Of Proinsulin
510(k) Number K951848
Device Name AIA-PACK CPR ASSAY
Applicant
Tosoh Medics, Inc.
373 D Vintage Park Dr.
Foster City,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
Tosoh Medics, Inc.
373 D Vintage Park Dr.
Foster City,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number862.1135
Classification Product Code
JKD  
Date Received04/21/1995
Decision Date 02/13/1996
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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