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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 K940971
Device Name AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
Applicant
Heraeus Kulzer, Inc.
1127 Myrtle St.
Elkhart,  IN  46514
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
1127 Myrtle St.
Elkhart,  IN  46514
Correspondent Contact ROSANNE M SAVOL
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
GFS  
Date Received03/02/1994
Decision Date 07/19/1994
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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