JZJ · Class I · 21 CFR 866.5060

FDA Product Code JZJ: Prealbumin, Antigen, Antiserum, Control

Leading manufacturers include Kent Laboratories, Inc., The Binding Site, Ltd. and Boehringer Mannheim Corp..

11
Total
11
Cleared
111d
Avg days
1978
Since

FDA 510(k) Cleared Prealbumin, Antigen, Antiserum, Control Devices (Product Code JZJ)

11 devices
1–11 of 11
Cleared Apr 13, 2000
RANDOX PREALBUMIN
K000661
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Jan 09, 1998
TINA-QUANT PREALBUMIN
K972638
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jun 01, 1995
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K951966
Kent Laboratories, Inc.
Immunology · 35d
Cleared Dec 20, 1991
PREALBUMIN IMMUNOLOGICAL NL TEST KIT
K913672
The Binding Site, Ltd.
Immunology · 123d
Cleared Sep 22, 1988
QM300 PREALBUMIN ANTIBODY PACK
K883002
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN PREALBUMIN
K850686
Kent Laboratories, Inc.
Immunology · 253d
Cleared Jun 21, 1985
LASER PREALBUMIN TEST
K851912
Behring Diagnostics, Inc.
Immunology · 51d
Cleared May 05, 1983
PREALBUMIN ENZYME IMMUNOASSAY
K821135
Abbott Laboratories
Hematology · 380d
Cleared Feb 03, 1978
LAS-R HUMAN PREALBUMIN TEST
K772329
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 44d

About Product Code JZJ - Regulatory Context