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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 K880718
Device Name CALCOFLUOR WHITE STAIN KIT
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact BRENDA HENRY
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact BRENDA HENRY
Regulation Number864.1850
Classification Product Code
JTS  
Date Received02/23/1988
Decision Date 03/25/1988
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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