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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 K971177
Device Name IMMULITE VITAMIN B12 (LKVB1,LKVB5)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Code
JIT  
Date Received03/31/1997
Decision Date 05/16/1997
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
Recalls CDRH Recalls
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