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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K761214
Device Name WELL COUNTERS, LOGIC II (200 SERIES)
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received12/07/1976
Decision Date 12/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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