DAD · Class II · 21 CFR 866.5460

FDA Product Code DAD: Haptoglobin, Antigen, Antiserum, Control

Leading manufacturers include Kent Laboratories, Inc., Kallestad Diag, A Div. of Erbamont, Inc. and Unipath , Ltd..

18
Total
18
Cleared
64d
Avg days
1976
Since

FDA 510(k) Cleared Haptoglobin, Antigen, Antiserum, Control Devices (Product Code DAD)

18 devices
1–18 of 18
Cleared Nov 24, 1999
K-ASSAY HAPTOGLOBIN
K993480
Kamiya Biomedical Co.
Immunology · 41d
Cleared Jan 09, 1998
TINA-QUANT HAPTOGLOBIN
K972639
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964301
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Oct 07, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
K963286
Beckman Instruments, Inc.
Immunology · 47d
Cleared Jul 17, 1995
N/T PROTEIN CONTROL SY/L, M AND H
K952593
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 29, 1992
IL TEST(TM) HAPTOGLOBIN (HPT)
K915829
Instrumentation Laboratory CO
Immunology · 212d
Cleared May 08, 1991
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898
Reagents Applications, Inc.
Immunology · 12d
Cleared Oct 20, 1987
HAPTOGLOBIN
K873866
Unipath , Ltd.
Immunology · 57d
Cleared Jul 21, 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 11d
Cleared Jul 18, 1983
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957
Kent Laboratories, Inc.
Chemistry · 31d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO
K812494
Dako Corp.
Immunology · 23d
Cleared Jul 08, 1980
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K801433
J.T. Baker Chemical Co.
Immunology · 20d
Cleared Dec 22, 1977
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K772245
Kallestad Laboratories, Inc.
Immunology · 13d

About Product Code DAD - Regulatory Context