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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 K923925
Device Name HCG STAT-PAK
Applicant
Chembio Diagnostic Systems, Inc.
3661 Horseblock Rd.
Medford,  NY  11763
Applicant Contact PAUL C REITER
Correspondent
Chembio Diagnostic Systems, Inc.
3661 Horseblock Rd.
Medford,  NY  11763
Correspondent Contact PAUL C REITER
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/05/1992
Decision Date 12/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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