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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 K011550
Device Name HCG STAT PAK ULTRA-FAST
Applicant
Chembio Diagnostic Systems, Inc.
163 Cabot St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Chembio Diagnostic Systems, Inc.
163 Cabot St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/18/2001
Decision Date 08/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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