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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 K920975
Device Name BACTIDROP CALCOFLUOR WHITE
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact ANN SILVIUS
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact ANN SILVIUS
Regulation Number864.1850
Classification Product Code
JTS  
Date Received03/02/1992
Decision Date 06/09/1992
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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