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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K881693
Device Name TERUMO SENSIBEAD EIA PROGESTERONE KIT
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact ALAN B HERSHMAN
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact ALAN B HERSHMAN
Regulation Number862.1150
Classification Product Code
JIS  
Date Received04/19/1988
Decision Date 06/07/1988
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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