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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 K800388
Device Name NML 5000 AUTO. GAMMA SCINT. COUNTER
Applicant
Nuclear Medical Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nuclear Medical Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received02/25/1980
Decision Date 03/12/1980
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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