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DAO — Igm (Mu Chain Specific), Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DAO
Device Class
Class II
Regulation Number
866.5550
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040431roche diagnosticsROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2March 10, 2004
K982639helena laboratoriesSPIFE URINE IFENovember 4, 1998
K955908boehringer mannheimBOEHRINGER MANNHEIM IGM ASSAYFebruary 9, 1996
K850586applications labSPQ TEST SYSTEM FOR IMMUNOGLOBULIN MMarch 14, 1985
K841992advanced cardiovascular systemsMODIFICATION TO ACS CORONARY GUIDINGJune 11, 1984
K812487dakoIMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMSeptember 23, 1981
K800450electro-nucleonics laboratoriesGEMENI IGM ASSAYApril 24, 1980
K790705kent laboratoriesANTISERUM TO HUMAN IGMApril 12, 1979