LKP · Class II · 21 CFR 866.5100

FDA Product Code LKP: Anti-sm Antibody, Antigen And Control

Leading manufacturers include Phadia AB, Bio-Rad and Diagnostic Chemicals, Ltd. (Usa).

28
Total
28
Cleared
99d
Avg days
1984
Since

FDA 510(k) Cleared Anti-sm Antibody, Antigen And Control Devices (Product Code LKP)

28 devices
1–24 of 28
Cleared Jul 14, 2021
EliA SmDP-S
K202067
Phadia AB
Immunology · 352d
Cleared Dec 24, 2018
EliA SmDP Immunoassay
K183007
Phadia AB
Immunology · 54d
Cleared Apr 17, 2013
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
K123593
Inova Diagnostics, Inc.
Immunology · 147d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219
Bio-Rad
Immunology · 23d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479
Bio-Rad
Immunology · 6d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
K983420
Zeus Scientific, Inc.
Immunology · 50d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (SM)
K954896
Hycor Biomedical, Inc.
Immunology · 185d
Cleared May 11, 1993
SYNELISA SM ABS/RNP-SM ABS
K930141
Elias U.S.A., Inc.
Immunology · 119d
Cleared Jun 25, 1984
ENZYMATIC ACETAMINOPHEN ASSAY
K841930
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 46d

About Product Code LKP - Regulatory Context