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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 K770165
Device Name MICRO-MIX PIPETTE SHAKER
Applicant
MADDAK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MADDAK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2050
Classification Product Code
JRQ  
Date Received01/25/1977
Decision Date 01/31/1977
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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