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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K913622
Device Name HEMOPLUS
Applicant
Sarstedt, Inc.
P.O. Box 468, Rt 2, St. James
Church Rd.
Newton,  NC  28658
Applicant Contact JAMES E YANCSEK
Correspondent
Sarstedt, Inc.
P.O. Box 468, Rt 2, St. James
Church Rd.
Newton,  NC  28658
Correspondent Contact JAMES E YANCSEK
Regulation Number864.6550
Classification Product Code
KHE  
Date Received08/14/1991
Decision Date 01/31/1992
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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