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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Micro Pipette
510(k) Number K792696
Device Name MICROPITETTE
Applicant
Meridian Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Meridian Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2050
Classification Product Code
JRC  
Date Received12/27/1979
Decision Date 02/01/1980
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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