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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 K872430
Device Name ISO-DATA 500 SERIES GAMMA COUNTER
Applicant
Iso-Data, Inc.
1500 Hicks Rd.
Rolling Meadows,  IL  60008
Applicant Contact JOHN M HOLUB
Correspondent
Iso-Data, Inc.
1500 Hicks Rd.
Rolling Meadows,  IL  60008
Correspondent Contact JOHN M HOLUB
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received06/22/1987
Decision Date 08/21/1987
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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