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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 K902455
Device Name ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
Applicant
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Applicant Contact W BONDERMAN
Correspondent
Analytical Control Systems, Inc.
9058 Technology Dr.
Fishers,  IN  46038
Correspondent Contact W BONDERMAN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/04/1990
Decision Date 07/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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