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JZJ — Prealbumin, Antigen, Antiserum, Control Class I

FDA Device Classification

Classification Details

Product Code
JZJ
Device Class
Class I
Regulation Number
866.5060
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K000661randox laboratoriesRANDOX PREALBUMINApril 13, 2000
K972638boehringer mannheimTINA-QUANT PREALBUMINJanuary 9, 1998
K951966kent laboratoriesHUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITJune 1, 1995
K913672binding sitePREALBUMIN IMMUNOLOGICAL NL TEST KITDecember 20, 1991
K884297atlantic antibodiesSPQ(TM) TEST SYSTEM FOR PREALBUMINNovember 2, 1988
K884298atlantic antibodiesSPQ(TM) TEST SYSTEM FOR MICROALBUMINNovember 2, 1988
K883002kallestad diag, a div. of erbamontQM300 PREALBUMIN ANTIBODY PACKSeptember 22, 1988
K850686kent laboratoriesANTISERUM TO HUMAN PREALBUMINNovember 1, 1985
K851912behring diagnosticsLASER PREALBUMIN TESTJune 21, 1985
K821135abbott laboratoriesPREALBUMIN ENZYME IMMUNOASSAYMay 5, 1983
K772329hyland therapeutic div., travenol laboratoriesLAS-R HUMAN PREALBUMIN TESTFebruary 3, 1978