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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Microbial Growth
510(k) Number K842279
Device Name BECTEC NR-660 BACTERIAL DETECT SYS
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2560
Classification Product Code
JTA  
Date Received06/08/1984
Decision Date 07/20/1984
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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