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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 K943239
Device Name VISUALINE II HCG
Applicant
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Applicant Contact MING SUN
Correspondent
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Correspondent Contact MING SUN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/06/1994
Decision Date 12/07/1994
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
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