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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 K900087
Device Name GENESYS 6000 GAMMA COUNTER
Applicant
Laboratory Technologies, Inc.
1517 S. Wright
Schaumburg,  IL  60193
Applicant Contact J SCHMIDT
Correspondent
Laboratory Technologies, Inc.
1517 S. Wright
Schaumburg,  IL  60193
Correspondent Contact J SCHMIDT
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received01/05/1990
Decision Date 07/19/1990
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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