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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 K972265
Device Name A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
Applicant
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/17/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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