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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 K890549
Device Name VENTREX COATED TUBE HCG
Applicant
Ventrex Laboratories, Inc.
217 Read St.
P.O. Box 9731
Portland,  ME  04103
Applicant Contact JAMES W CHAMPLIN
Correspondent
Ventrex Laboratories, Inc.
217 Read St.
P.O. Box 9731
Portland,  ME  04103
Correspondent Contact JAMES W CHAMPLIN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received02/03/1989
Decision Date 03/28/1989
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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