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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 K892224
Device Name D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
Applicant
Photec Diagnostics, Inc.
101 E. Main St.
Little Falls,  NJ  07424
Applicant Contact BARRY MCDONALD
Correspondent
Photec Diagnostics, Inc.
101 E. Main St.
Little Falls,  NJ  07424
Correspondent Contact BARRY MCDONALD
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received04/03/1989
Decision Date 06/16/1989
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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