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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K860156
Device Name NEISSERIASTAT
Applicant
Richardson Scientific, Inc.
2227 Flat Creek
Richardson,  TX  75080
Applicant Contact G. W CARTWRIGHT,PHD
Correspondent
Richardson Scientific, Inc.
2227 Flat Creek
Richardson,  TX  75080
Correspondent Contact G. W CARTWRIGHT,PHD
Regulation Number866.2660
Classification Product Code
JTO  
Date Received01/16/1986
Decision Date 03/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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