CZP · Class II · 21 CFR 866.5510

FDA Product Code CZP: Iga, Antigen, Antiserum, Control

Leading manufacturers include Boehringer Mannheim Corp., Abbott Laboratories and E.I. Dupont DE Nemours & Co., Inc..

54
Total
54
Cleared
48d
Avg days
1976
Since

FDA 510(k) Cleared Iga, Antigen, Antiserum, Control Devices (Product Code CZP)

54 devices
1–24 of 54
Cleared Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525
HORIBA ABX SAS
Immunology · 190d
Cleared Feb 13, 2006
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130
Beckman Coulter, Inc.
Immunology · 26d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435
Roche Diagnostics Corp.
Immunology · 20d
Cleared Feb 13, 2003
N LATEX IGA
K024038
Dade Behring, Inc.
Immunology · 69d
Cleared Nov 04, 1998
IGA
K983359
Abbott Laboratories
Immunology · 41d
Cleared Sep 25, 1996
QUANTEX IGA
K962200
Instrumentation Laboratory CO
Immunology · 110d
Cleared Feb 09, 1996
BOEHRINGER MANNHEIM IGA ASSAY
K955907
Boehringer Mannheim Corp.
Immunology · 42d
Cleared Jun 20, 1995
N LATEX IGA
K952309
Behring Diagnostics, Inc.
Immunology · 34d
Cleared Jun 16, 1992
IL TEST IMMUNOGLOBULIN A
K920014
Instrumentation Laboratory CO
Immunology · 166d
Cleared Feb 27, 1990
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422
Helena Laboratories
Immunology · 28d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 17, 1986
PRECIMAT (R) IGA, G, M
K863352
Boehringer Mannheim Corp.
Immunology · 19d
Cleared Sep 04, 1986
TINA-QUANT(R) IGA
K862763
Boehringer Mannheim Corp.
Immunology · 44d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046
Abbott Laboratories
Immunology · 253d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468
Miles Laboratories, Inc.
Immunology · 64d
Cleared Dec 30, 1982
IMMUNOGLOBULIN CONTROL
K823566
Syva Co.
Chemistry · 27d
Cleared Dec 30, 1982
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
K823567
Syva Co.
Immunology · 27d
Cleared Aug 03, 1982
IMMUNO DIAGNOSTICS ASSAY
K822026
Helena Laboratories
Chemistry · 22d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN A TEST PACK
K812631
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGA
K791401
Sherwood Medical Co.
Immunology · 79d
Cleared Apr 03, 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479
Abbott Laboratories
Chemistry · 26d
Cleared Sep 15, 1977
IMMOCHEMISTRY SYSTEM
K771603
Beckman Instruments, Inc.
Immunology · 24d

About Product Code CZP - Regulatory Context