Panels › Immunology › Product code LKP · Class 2
Anti-Sm Antibody, Antigen And Control
Regulation 866.5100
0510(k)s in 12 months (28 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LKP
| Company | 510(k)s | Recalls |
|---|---|---|
| Phadia AB | 2 | 1 |
| Bio-Rad | 2 | 0 |
| General Biometrics, Inc. | 2 | 0 |
| Lipogen, Inc. | 2 | 0 |
| Quest Intl., Inc. | 2 | 0 |
| Shield Diagnostics, Ltd. | 2 | 0 |
| American Bionetics, Inc. | 1 | 0 |
| Cogent Diagnotics , Ltd. | 1 | 0 |
| Diagnostic Chemicals, Ltd. (Usa) | 1 | 0 |
| Elias U.S.A., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 2021 | K202067 | EliA SmDP-S Phadia AB, SE | LKP |
| Dec 24, 2018 | K183007 | EliA SmDP Immunoassay Phadia AB, SE | LKP |
| Aug 29, 2014 | K132631 | EIA SMDP IMMUNOASSAY Phadia US, Inc. | LKP |
| Apr 17, 2013 | K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, Inova Diagnostics, Inc. | LKP |
| Oct 7, 2005 | K051066 | THERATEST EL-ANA PROFILES Theratest Laboratories, Inc. | LKP |
| Dec 8, 2004 | K042629 | VARELISA SM ANTIBODIES, MODEL 18296 Sweden Diagnostics (Germany) GmbH, DE | LKP |
| Jan 15, 2003 | K024219 | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 Bio-Rad | LKP |
| Jul 29, 2002 | K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST Fred Hutchinson Cancer Research Center | LKP |
| May 9, 2000 | K000755 | RHIGENE MESACUP2 TEST- SM Rhigene, Inc. | LKP |
| Mar 17, 2000 | K000312 | VARELISA SM ANTIBODIES Pharmacia & Upjohn Co. | LKP |
| Apr 28, 1999 | K990625 | AUTOSTAT II ANTI-SM ELISA Cogent Diagnotics , Ltd., GB | LKP |
| Dec 22, 1998 | K984479 | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 Bio-Rad | LKP |
| Nov 18, 1998 | K983420 | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO Zeus Scientific, Inc. | LKP |
| Jun 15, 1998 | K980540 | SERAQUEST ANTI-SM Quest Intl., Inc. | LKP |
| May 12, 1998 | K980811 | SERAQUEST ANTI-SM/RNP Quest Intl., Inc. | LKP |
| May 8, 1996 | K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY Orgentec | LKP |
| Mar 22, 1996 | K954896 | HYTEC AUTOIMMUNE KITS (SM) Hycor Biomedical, Inc. | LKP |
| Apr 20, 1994 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT Helix Diagnostics, Inc. | LKP |
| May 11, 1993 | K930141 | SYNELISA SM ABS/RNP-SM ABS Elias U.S.A., Inc. | LKP |
| May 7, 1991 | K911851 | IMMUNOWELL SM ANTIBODY TEST General Biometrics, Inc. | LKP |
| May 7, 1991 | K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST General Biometrics, Inc. | LKP |
| Dec 7, 1990 | K905192 | DIASTAT ANTI-SM/RNP Shield Diagnostics, Ltd., KN | LKP |
| Dec 7, 1990 | K905191 | DIASTAT ANTI-SM Shield Diagnostics, Ltd., KN | LKP |
| Nov 6, 1989 | K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES Lipogen, Inc. | LKP |
| May 16, 1988 | K881379 | WESBLOT RNP-SM TEST American Bionetics, Inc. | LKP |
| Apr 6, 1988 | K880254 | SM ANTIBODY TEST KIT Lipogen, Inc. | LKP |
| Nov 4, 1987 | K873741 | IMMUSTRIP(TM) SM ELISA TEST SYSTEM Immunomedics, Inc. | LKP |
| Jun 25, 1984 | K841930 | ENZYMATIC ACETAMINOPHEN ASSAY Diagnostic Chemicals, Ltd. (Usa) | LKP |
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