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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Calcium
510(k) Number K884731
Device Name LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
Applicant
Amdev, Inc.
35 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact CONNIE J HERTEL
Correspondent
Amdev, Inc.
35 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact CONNIE J HERTEL
Regulation Number862.1145
Classification Product Code
JFP  
Date Received11/10/1988
Decision Date 02/03/1989
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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