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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 K822944
Device Name GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
Applicant
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TRAVENOL LABORATORIES, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1545
Classification Product Code
CEW  
Date Received10/04/1982
Decision Date 12/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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