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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 K932153
Device Name THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME
Applicant
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number892.1320
Classification Product Code
IZD  
Date Received05/04/1993
Decision Date 09/07/1993
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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