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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hematocrit
510(k) Number K964452
Device Name HEMATACHEK
Applicant
Richmond Diagnostics, Inc.
100 Jersey Ave., Suite 202a,
Bldg. B
New Brunswick,  NJ  08901
Applicant Contact JOSEPH P PINENO
Correspondent
Richmond Diagnostics, Inc.
100 Jersey Ave., Suite 202a,
Bldg. B
New Brunswick,  NJ  08901
Correspondent Contact JOSEPH P PINENO
Regulation Number864.8625
Classification Product Code
GLK  
Date Received11/06/1996
Decision Date 02/20/1997
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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