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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 K970832
Device Name PYR SWAB
Applicant
Remel, Inc.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact MARY A SILVIUS
Correspondent
Remel, Inc.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact MARY A SILVIUS
Regulation Number866.2660
Classification Product Code
JTO  
Date Received03/07/1997
Decision Date 04/24/1997
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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