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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 K940006
Device Name IMMULITE THIRD GENERATION (MODIFICATION)
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact KENNETH B ASARCH, PHARM.D., PH.D
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact KENNETH B ASARCH, PHARM.D., PH.D
Regulation Number862.1690
Classification Product Code
JLW  
Date Received01/06/1994
Decision Date 12/19/1994
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
Recalls CDRH Recalls
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