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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Progesterone
510(k) Number K920230
Device Name AFFINITY PRG
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact JUDITH SMITH
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact JUDITH SMITH
Regulation Number862.1620
Classification Product Code
JLS  
Date Received01/17/1992
Decision Date 02/18/1992
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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