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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 K961965
Device Name SURE CHECK PREGNANCY TEST
Applicant
Chembio Diagnostic Systems, Inc.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Chembio Diagnostic Systems, Inc.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number862.1155
Classification Product Code
LCX  
Date Received05/20/1996
Decision Date 06/24/1996
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
Recalls CDRH Recalls
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