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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 K832734
Device Name KEMTEK 400 RIA GAMMA COUNTER
Applicant
Kemble Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kemble Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received08/04/1983
Decision Date 10/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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