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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dye-Indicator, Ph (Urinary, Non-Quantitative)
510(k) Number K051727
Device Name AIMSTICK URINE REAGENT STRIPS
Applicant
Germaine Laboratories, Inc.
4139 Gardendale Center,
Suite 101
San Antonio,  TX  78229
Applicant Contact MARTIN O'CONNOR
Correspondent
Germaine Laboratories, Inc.
4139 Gardendale Center,
Suite 101
San Antonio,  TX  78229
Correspondent Contact MARTIN O'CONNOR
Regulation Number862.1550
Classification Product Code
CEN  
Date Received06/28/2005
Decision Date 10/26/2005
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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