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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram Positive Identification Panel
510(k) Number K891004
Device Name RAPIDEC STAPH
Applicant
Dms Products, Inc.
Dart'S Mill Professional Vill.
Rt. 523, Box 95
Flemington,  NJ  08822
Applicant Contact JANIS FREESTONE
Correspondent
Dms Products, Inc.
Dart'S Mill Professional Vill.
Rt. 523, Box 95
Flemington,  NJ  08822
Correspondent Contact JANIS FREESTONE
Regulation Number866.2660
Classification Product Code
LQL  
Date Received02/28/1989
Decision Date 11/09/1989
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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