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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shaker/Stirrer
510(k) Number K801145
Device Name SMI MULTI-TUBE VORTEXER
Applicant
Scientific Manufacturing Industries
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Scientific Manufacturing Industries
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2050
Classification Product Code
JRQ  
Date Received05/13/1980
Decision Date 06/09/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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