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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Red-Cell Lysing Products
510(k) Number K874054
Device Name FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
Applicant
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Applicant Contact B BREUER,PHD
Correspondent
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Correspondent Contact B BREUER,PHD
Regulation Number864.8540
Classification Product Code
GGK  
Date Received10/05/1987
Decision Date 10/20/1987
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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