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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K980088
Device Name T-UPTAKE MICROPLATE EIA
Applicant
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Applicant Contact FREDERICK R JEROME
Correspondent
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Correspondent Contact FREDERICK R JEROME
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received01/09/1998
Decision Date 02/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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