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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K854670
Device Name TERUMO SENSIBEAD EIG HCG KIT
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact HARALD JACOBY
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact HARALD JACOBY
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received11/21/1985
Decision Date 02/13/1986
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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