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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 K971209
Device Name CLINITEK HCG TEST STRIPS
Applicant
Bayer Corp.
1884 Miles Ave.
Elkhart,  IN  46514
Applicant Contact ROSEANNE SAVOL
Correspondent
Rdd Consultants, Inc.
401 Spruce St.
Louisville,  CO  80027
Correspondent Contact NANCY SAUER
Regulation Number862.1155
Classification Product Code
JHI  
Date Received04/02/1997
Decision Date 04/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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