Product code JZJ— Immunology

FDA has cleared 11 devices under product code JZJ between 1978 and 2000, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20001 clearance
• 19981 clearance
• 19951 clearance
• 19911 clearance
• 19883 clearances
• 19852 clearances
• 19831 clearance
• 19781 clearance

• Kent Laboratories, Inc.2 clearances
• Atlantic Antibodies2 clearances
• The Binding Site, Ltd.1 clearance
• Randox Laboratories, Ltd.1 clearance
• Kallestad Diag, A Div. of Erbamont, Inc.1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Boehringer Mannheim Corp.1 clearance
• Behring Diagnostics, Inc.1 clearance
• Abbott Laboratories1 clearance

• K000661 — RANDOX PREALBUMINRandox Laboratories, Ltd.·2000-04-13
• K972638 — TINA-QUANT PREALBUMINBoehringer Mannheim Corp.·1998-01-09
• K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.·1995-06-01
• K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.·1991-12-20
• K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMINAtlantic Antibodies·1988-11-02
• K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMINAtlantic Antibodies·1988-11-02
• K883002 — QM300 PREALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.·1988-09-22
• K850686 — ANTISERUM TO HUMAN PREALBUMINKent Laboratories, Inc.·1985-11-01
• K851912 — LASER PREALBUMIN TESTBehring Diagnostics, Inc.·1985-06-21
• K821135 — PREALBUMIN ENZYME IMMUNOASSAYAbbott Laboratories·1983-05-05
• K772329 — LAS-R HUMAN PREALBUMIN TESTHyland Therapeutic Div., Travenol Laboratories·1978-02-03