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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 K902136
Device Name KODAK SURECELL(TM) HCG-URINE TEST KIT
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact NORMAN H GEIL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact NORMAN H GEIL
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/10/1990
Decision Date 06/28/1990
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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