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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K874662
Device Name MYCO-FLUOR REAGENT A & B
Applicant
Scott Laboratories, Inc.
190 N. Cities Service Hwy.
Sulphur,  LA  70663
Applicant Contact CHRISOPE, PHD
Correspondent
Scott Laboratories, Inc.
190 N. Cities Service Hwy.
Sulphur,  LA  70663
Correspondent Contact CHRISOPE, PHD
Regulation Number864.1850
Classification Product Code
JTS  
Date Received11/13/1987
Decision Date 11/25/1987
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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