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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 K860815
Device Name SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact PAUL DURHAM
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact PAUL DURHAM
Regulation Number862.1810
Classification Product Code
CDD  
Date Received03/04/1986
Decision Date 07/11/1986
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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