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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood, Occult, Colorimetric, In Urine
510(k) Number K905396
Device Name HEMASTIX REAGENT STRIPS
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 Number864.6550
Classification Product Code
JIO  
Date Received11/30/1990
Decision Date 02/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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