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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 K991532
Device Name DRX QT. HCG
Applicant
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085 -4022
Applicant Contact YA-CHEN HSU
Correspondent
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE,  CA  94085 -4022
Correspondent Contact YA-CHEN HSU
Regulation Number862.1155
Classification Product Code
DHA  
Date Received05/03/1999
Decision Date 09/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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