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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 K952319
Device Name CONTRAST & RAPID HCG URINE/SERUM TST
Applicant
Medix Biotech, Inc.
1531 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact PAUL LADDEN
Correspondent
Medix Biotech, Inc.
1531 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact PAUL LADDEN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/18/1995
Decision Date 06/20/1995
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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