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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K940577
Device Name GLUCOMETER ELITE LOW CONTROL
Applicant
Heraeus Kulzer, Inc.
430 S. Beiger St.
P.O. Box 2004
Mishawaka,  IN  46546
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
430 S. Beiger St.
P.O. Box 2004
Mishawaka,  IN  46546
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1660
Classification Product Code
JJX  
Date Received02/08/1994
Decision Date 06/13/1994
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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