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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioassay, vitamin b12
510(k) Number K924074
Device Name STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
Applicant
BAXTER DIAGNOSTICS, INC.
P.O. BOX 520672
MIAMI,  FL  33152
Applicant Contact NANCY A HORNBAKER
Correspondent
BAXTER DIAGNOSTICS, INC.
P.O. BOX 520672
MIAMI,  FL  33152
Correspondent Contact NANCY A HORNBAKER
Regulation Number862.1810
Classification Product Code
CDD  
Date Received08/12/1992
Decision Date 10/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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