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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K011434
Device Name G7 AUTOMATED HPLC ANALYZER
Applicant
Tosoh Medics, Inc.
347 Oyster Point Blvd.,
Suite 201
South San Francisco,  CA  94080
Applicant Contact LOIS NAKAYAMA
Correspondent
Tosoh Medics, Inc.
347 Oyster Point Blvd.,
Suite 201
South San Francisco,  CA  94080
Correspondent Contact LOIS NAKAYAMA
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/10/2001
Decision Date 09/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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