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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 K973702
Device Name ELECSYS VITAMIN B12 ASSAY
Applicant
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact YVETTE R LLOYD
Correspondent
Boehringer Mannheim Corp.
4300 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact YVETTE R LLOYD
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Code
JIS  
Date Received09/26/1997
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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