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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K862083
Device Name HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
Applicant
HYGEIA SCIENCES
330 NEVADA ST.
NEWTON,  MA  02160
Applicant Contact IZAK BAHAR
Correspondent
HYGEIA SCIENCES
330 NEVADA ST.
NEWTON,  MA  02160
Correspondent Contact IZAK BAHAR
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received06/02/1986
Decision Date 07/02/1986
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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