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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 K870751
Device Name SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
Applicant
Syntron Bioresearch, Inc.
4202 Sorrento Valley Blvd.
Suite G
San Diego,  CA  92121
Applicant Contact SHUNG-HO CHANG
Correspondent
Syntron Bioresearch, Inc.
4202 Sorrento Valley Blvd.
Suite G
San Diego,  CA  92121
Correspondent Contact SHUNG-HO CHANG
Regulation Number862.1155
Classification Product Code
JHI  
Date Received02/25/1987
Decision Date 05/20/1987
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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