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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Clearing
510(k) Number K853694
Device Name XYLENE SUBSTITUTE
Applicant
Lerner Laboratories, Inc.
17 James St.
New Haven,  CT  06513
Applicant Contact SUSAN E SEGAL
Correspondent
Lerner Laboratories, Inc.
17 James St.
New Haven,  CT  06513
Correspondent Contact SUSAN E SEGAL
Regulation Number864.4010
Classification Product Code
KEM  
Date Received09/04/1985
Decision Date 10/22/1985
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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