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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 K922290
Device Name SINGLE-STEP PREGNANCY, HCG TEST
Applicant
American Medical Products, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Applicant Contact MARTIN R GOULD
Correspondent
American Medical Products, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Correspondent Contact MARTIN R GOULD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/15/1992
Decision Date 07/09/1992
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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