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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K903566
Device Name DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
Applicant
Baxter Healthcare Corp
11210 Malcolm Mckinley Dr.
Tampa,  FL  33612
Applicant Contact NANCY A HORNBAKER
Correspondent
Baxter Healthcare Corp
11210 Malcolm Mckinley Dr.
Tampa,  FL  33612
Correspondent Contact NANCY A HORNBAKER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/07/1990
Decision Date 09/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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