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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixative, Formalin-Containing
510(k) Number K880549
Device Name DIACYTE FIXATIVE SOLUTION
Applicant
Cytocorp, Inc.
601 Rockwell Ave.
Suite 314
Cleveland,  OH  44114
Applicant Contact KAY MAKSEM
Correspondent
Cytocorp, Inc.
601 Rockwell Ave.
Suite 314
Cleveland,  OH  44114
Correspondent Contact KAY MAKSEM
Regulation Number864.4010
Classification Product Code
LDY  
Date Received02/09/1988
Decision Date 04/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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