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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 K023944
Device Name BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
Applicant
Bayer Corp.
63 N. St.
Medfield,  MA  02052 -1688
Applicant Contact THOMAS F FLYNN
Correspondent
Bayer Corp.
63 N. St.
Medfield,  MA  02052 -1688
Correspondent Contact THOMAS F FLYNN
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/26/2002
Decision Date 02/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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