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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K913055
Device Name THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900
Applicant
Atomic Products Corp.
P.O. Drawer R
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Atomic Products Corp.
P.O. Drawer R
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number892.1320
Classification Product Code
IZD  
Date Received07/09/1991
Decision Date 09/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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