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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 K851377
Device Name DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
Applicant
Diagnon Corp.
Phair Office Park
1050 W. St.
Laurel,  MD  20707
Applicant Contact MARIE T PERLSTEIN
Correspondent
Diagnon Corp.
Phair Office Park
1050 W. St.
Laurel,  MD  20707
Correspondent Contact MARIE T PERLSTEIN
Regulation Number862.1810
Classification Product Code
CDD  
Date Received04/08/1985
Decision Date 08/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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