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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K782081
Device Name RIA SYSTEM, PARATHYROID HORMONE
Applicant
Iso-Tex Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Iso-Tex Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1545
Classification Product Code
CEW  
Date Received12/13/1978
Decision Date 03/21/1979
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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