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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827748
Device Name THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE
Applicant
Kemble Instruments, Inc.
174 Mine Lake Ct. Suite 100
Raleigh,  NC  27615
Correspondent
Kemble Instruments, Inc.
174 Mine Lake Ct. Suite 100
Raleigh,  NC  27615
Date Received07/20/1982
Decision Date 08/16/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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