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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K925880
Device Name KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact BRADFORD M SPRING
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact BRADFORD M SPRING
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/19/1992
Decision Date 02/05/1993
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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