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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 K020378
Device Name QUPID PLUS E.R.
Applicant
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Applicant Contact KIRK JOHNSON
Correspondent
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Correspondent Contact KIRK JOHNSON
Regulation Number862.1155
Classification Product Code
JHI  
Date Received02/05/2002
Decision Date 06/21/2002
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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