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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 K913010
Device Name BACTIDROP (TM) NITRATE B
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 Number866.2660
Classification Product Code
JTO  
Date Received07/08/1991
Decision Date 09/19/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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