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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 K936138
Device Name KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650 -1131
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650 -1131
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.1155
Classification Product Code
JHI  
Date Received12/23/1993
Decision Date 04/08/1994
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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