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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K882192
Device Name HYGEIA URINE PREGNANCY TEST
Applicant
Hygeia Sciences
330 Nevada St.
Newton,  MA  02160
Applicant Contact CANNON, PHD
Correspondent
Hygeia Sciences
330 Nevada St.
Newton,  MA  02160
Correspondent Contact CANNON, PHD
Regulation Number862.1155
Classification Product Code
DHA  
Date Received05/25/1988
Decision Date 11/10/1988
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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