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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Red-Cell Indices
510(k) Number K862089
Device Name V-MARC 88A COMPUTER
Applicant
V.Marc, A Div. of Pictorial, Inc.
8081 Zionsville Rd.
Box 68886
Indianapolis,  IN  46268
Applicant Contact JAMES M CONNOLLY
Correspondent
V.Marc, A Div. of Pictorial, Inc.
8081 Zionsville Rd.
Box 68886
Indianapolis,  IN  46268
Correspondent Contact JAMES M CONNOLLY
Regulation Number864.5300
Classification Product Code
KQH  
Date Received06/02/1986
Decision Date 07/10/1986
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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