| EliA SmDP-S (K202067) | Phadia AB | 2021-07-14 |
| EliA SmDP Immunoassay (K183007) | Phadia AB | 2018-12-24 |
| EIA SMDP IMMUNOASSAY (K132631) | Phadia US, Inc. | 2014-08-29 |
| QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, (K123593) | Inova Diagnostics, Inc. | 2013-04-17 |
| THERATEST EL-ANA PROFILES (K051066) | Theratest Laboratories, Inc. | 2005-10-07 |
| VARELISA SM ANTIBODIES, MODEL 18296 (K042629) | Sweden Diagnostics (Germany) GmbH | 2004-12-08 |
| LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (K024219) | Bio-Rad | 2003-01-15 |
| FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (K013263) | Fred Hutchinson Cancer Research Center | 2002-07-29 |
| RHIGENE MESACUP2 TEST- SM (K000755) | Rhigene, Inc. | 2000-05-09 |
| VARELISA SM ANTIBODIES (K000312) | Pharmacia & Upjohn Co. | 2000-03-17 |
| AUTOSTAT II ANTI-SM ELISA (K990625) | Cogent Diagnotics , Ltd. | 1999-04-28 |
| LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 (K984479) | Bio-Rad | 1998-12-22 |
| THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO (K983420) | Zeus Scientific, Inc. | 1998-11-18 |
| SERAQUEST ANTI-SM (K980540) | Quest Intl., Inc. | 1998-06-15 |
| SERAQUEST ANTI-SM/RNP (K980811) | Quest Intl., Inc. | 1998-05-12 |
| ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY (K954830) | Orgentec | 1996-05-08 |
| HYTEC AUTOIMMUNE KITS (SM) (K954896) | Hycor Biomedical, Inc. | 1996-03-22 |
| ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (K940510) | Helix Diagnostics, Inc. | 1994-04-20 |
| SYNELISA SM ABS/RNP-SM ABS (K930141) | Elias U.S.A., Inc. | 1993-05-11 |
| IMMUNOWELL SM ANTIBODY TEST (K911851) | General Biometrics, Inc. | 1991-05-07 |
| IMMUNOWELL RNP/SM ANTIBODY TEST (K911848) | General Biometrics, Inc. | 1991-05-07 |
| DIASTAT ANTI-SM (K905191) | Shield Diagnostics, Ltd. | 1990-12-07 |
| DIASTAT ANTI-SM/RNP (K905192) | Shield Diagnostics, Ltd. | 1990-12-07 |
| RHEUMELISA ASSAY FOR SM AUTOANTIBODIES (K895996) | Lipogen, Inc. | 1989-11-06 |
| WESBLOT RNP-SM TEST (K881379) | American Bionetics, Inc. | 1988-05-16 |
| SM ANTIBODY TEST KIT (K880254) | Lipogen, Inc. | 1988-04-06 |
| IMMUSTRIP(TM) SM ELISA TEST SYSTEM (K873741) | Immunomedics, Inc. | 1987-11-04 |
| ENZYMATIC ACETAMINOPHEN ASSAY (K841930) | Diagnostic Chemicals, Ltd. (Usa) | 1984-06-25 |