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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 K951136
Device Name BIONIKE A/Q PREGNANCY TEST
Applicant
Charlton Assoc.
1206 Sesame Dr.
Sunnyvale,  CA  94087
Correspondent
Charlton Assoc.
1206 Sesame Dr.
Sunnyvale,  CA  94087
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/13/1995
Decision Date 04/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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