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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 K822078
Device Name DADE DISP. DISPENSING-SPREADING PIPETS
Applicant
American Dade
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Dade
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2050
Classification Product Code
JRC  
Date Received07/15/1982
Decision Date 07/27/1982
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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