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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K941771
Device Name BODYWISE PREGNANCEY TEST
Applicant
Charlton Assoc.
1206 Sesame Dr.
Sunnyvale,  CA  94087
Applicant Contact JANIS FREESTONE
Correspondent
Charlton Assoc.
1206 Sesame Dr.
Sunnyvale,  CA  94087
Correspondent Contact JANIS FREESTONE
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/11/1994
Decision Date 07/06/1994
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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