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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 K861168
Device Name CLEARBLUE PREGNANCY TESTING KIT
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Regulation Number862.1155
Classification Product Code
LCX  
Date Received03/28/1986
Decision Date 04/24/1986
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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