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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Microtiter Diluting/Dispensing
510(k) Number K810229
Device Name SCEPTOR SYSTEM AUTOMATED MODEL 216
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 Number866.2500
Classification Product Code
JTC  
Date Received01/27/1981
Decision Date 02/09/1981
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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