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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 K981165
Device Name AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
Applicant
Germaine Laboratories, Inc.
4203 Gardendale Center, #230
San Antonio,  TX  78229
Applicant Contact MARTIN O'CONNOR
Correspondent
Germaine Laboratories, Inc.
4203 Gardendale Center, #230
San Antonio,  TX  78229
Correspondent Contact MARTIN O'CONNOR
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/31/1998
Decision Date 04/16/1998
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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