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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K033114
Device Name KETOCHECKS
Applicant
Neo Diagnostics, Inc.
10532 Walker St.
Suite B
Cypress,  CA  90630
Applicant Contact SUNG PYO
Correspondent
Neo Diagnostics, Inc.
10532 Walker St.
Suite B
Cypress,  CA  90630
Correspondent Contact SUNG PYO
Regulation Number862.1435
Classification Product Code
JIN  
Date Received09/30/2003
Decision Date 04/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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