CZJ · Class II · 21 CFR 866.5510

FDA Product Code CZJ: Igd, Antigen, Antiserum, Control

Leading manufacturers include The Binding Site, Ltd., The Binding Site and Hyland Therapeutic Div., Travenol Laboratories.

8
Total
8
Cleared
87d
Avg days
1978
Since

FDA 510(k) Cleared Igd, Antigen, Antiserum, Control Devices (Product Code CZJ)

8 devices
1–8 of 8
Cleared Dec 28, 2009
HUMAN IGD KIT FOR USE ON SPAPLUS
K092450
The Binding Site
Immunology · 140d
Cleared Nov 23, 2005
IGD DIAGNOSTIC TEST KITS
K051299
The Binding Site, Ltd.
Immunology · 189d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
K002561
The Binding Site, Ltd.
Immunology · 70d
Cleared Dec 02, 1991
HUMAN IGD IMMUNOLOGICAL NL TEST KIT
K913671
The Binding Site, Ltd.
Immunology · 105d
Cleared Sep 22, 1988
QM300 CALIBRATOR D PACK
K883001
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Aug 12, 1987
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
K872834
Helena Laboratories
Immunology · 26d
Cleared Jul 18, 1983
DETERM. SIZE 72 RADIAL-HUMAN IGD
K831956
Kent Laboratories, Inc.
Chemistry · 31d
Cleared Feb 28, 1978
LAS-R HUMAN IGD TEST
K772327
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 69d

About Product Code CZJ - Regulatory Context