LKP · Class II · 21 CFR 866.5100

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

Leading manufacturers include Bio-Rad, Phadia AB and Shield Diagnostics, Ltd..

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 Aug 29, 2014
EIA SMDP IMMUNOASSAY
K132631
Phadia US, Inc.
Immunology · 372d
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 Oct 07, 2005
THERATEST EL-ANA PROFILES
K051066
Theratest Laboratories, Inc.
Immunology · 164d
Cleared Dec 08, 2004
VARELISA SM ANTIBODIES, MODEL 18296
K042629
Sweden Diagnostics (Germany) GmbH
Immunology · 72d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219
Bio-Rad
Immunology · 23d
Cleared Mar 17, 2000
VARELISA SM ANTIBODIES
K000312
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM ELISA
K990625
Cogent Diagnotics , Ltd.
Immunology · 62d
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 Jun 15, 1998
SERAQUEST ANTI-SM
K980540
Quest Intl., Inc.
Immunology · 123d
Cleared May 12, 1998
SERAQUEST ANTI-SM/RNP
K980811
Quest Intl., Inc.
Immunology · 70d
Cleared May 08, 1996
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830
Orgentec
Immunology · 201d
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 May 07, 1991
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SM ANTIBODY TEST
K911851
General Biometrics, Inc.
Immunology · 11d
Cleared Dec 07, 1990
DIASTAT ANTI-SM
K905191
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 07, 1990
DIASTAT ANTI-SM/RNP
K905192
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Jun 25, 1984
ENZYMATIC ACETAMINOPHEN ASSAY
K841930
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 46d

About Product Code LKP - Regulatory Context