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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 K851689
Device Name GENESYS GAMMA COUNTER
Applicant
Laboratory Technologies, Inc.
4n645 Mohican
Elburn,  IL  60119
Applicant Contact OESTELIN
Correspondent
Laboratory Technologies, Inc.
4n645 Mohican
Elburn,  IL  60119
Correspondent Contact OESTELIN
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received04/26/1985
Decision Date 08/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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