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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K850992
Device Name PREGNA-ZYME
Applicant
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Applicant Contact STEPHEN KOLAKOWSKY
Correspondent
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Correspondent Contact STEPHEN KOLAKOWSKY
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/11/1985
Decision Date 05/01/1985
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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