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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 K030533
Device Name ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
Applicant
Cenogenics Corp.
100 Rt. 520
Morganville,  NJ  07751
Applicant Contact NITZ KATZ
Correspondent
Cenogenics Corp.
100 Rt. 520
Morganville,  NJ  07751
Correspondent Contact NITZ KATZ
Regulation Number862.1155
Classification Product Code
LCX  
Date Received02/14/2003
Decision Date 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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