FDA.reportPublic FDA data

510(k) K821135

Device
Prealbumin Enzyme Immunoassay
Applicant
ABBOTT LABORATORIES
510(k) number
K821135
Product code
JZJ
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-05
Date received
1982-04-20
Regulation
866.5060
Classification name
Prealbumin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000661RANDOX PREALBUMINRandox Laboratories, Ltd.2000-04-13
K972638TINA-QUANT PREALBUMINBoehringer Mannheim Corp.1998-01-09
K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.1995-06-01
K913672PREALBUMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.1991-12-20
K884297SPQ(TM) TEST SYSTEM FOR PREALBUMINAtlantic Antibodies1988-11-02
K884298SPQ(TM) TEST SYSTEM FOR MICROALBUMINAtlantic Antibodies1988-11-02
K883002QM300 PREALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1988-09-22
K850686ANTISERUM TO HUMAN PREALBUMINKent Laboratories, Inc.1985-11-01
K851912LASER PREALBUMIN TESTBehring Diagnostics, Inc.1985-06-21
K772329LAS-R HUMAN PREALBUMIN TESTHyland Therapeutic Div., Travenol Laboratories1978-02-03