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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wright'S Stain
510(k) Number K853241
Device Name HEMATOLOGY STAIN PACK
Applicant
Fisher Scientific Co., LLC
1 Reagent Ln.
Fair Lawn,  NJ  07410
Applicant Contact JACK C MCLAUGHLIN
Correspondent
Fisher Scientific Co., LLC
1 Reagent Ln.
Fair Lawn,  NJ  07410
Correspondent Contact JACK C MCLAUGHLIN
Regulation Number864.1850
Classification Product Code
IAF  
Date Received08/01/1985
Decision Date 08/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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