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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Photometry, Lithium
510(k) Number K895465
Device Name AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
Applicant
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KRISTA U SMALLEY
Correspondent
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KRISTA U SMALLEY
Regulation Number862.3560
Classification Product Code
JIH  
Date Received09/11/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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