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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K081074
Device Name DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Mailbox 514
Newark,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Mailbox 514
Newark,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/16/2008
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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