FDA 510(k) Applications for Medical Device Product Code "LKP"
(Anti-Sm Antibody, Antigen And Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K984479 | BIO-RAD | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | 12/22/1998 |
| K024219 | BIO-RAD | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 | 01/15/2003 |
| K990625 | COGENT DIAGNOTICS LTD. | AUTOSTAT II ANTI-SM ELISA | 04/28/1999 |
| K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST | 07/29/2002 |
| K954896 | HYCOR BIOMEDICAL, INC. | HYTEC AUTOIMMUNE KITS (SM) | 03/22/1996 |
| K123593 | INOVA DIAGNOSTICS, INC. | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | 04/17/2013 |
| K954830 | ORGENTEC | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | 05/08/1996 |
| K183007 | Phadia AB | EliA SmDP Immunoassay | 12/24/2018 |
| K202067 | Phadia AB | EliA SmDP-S | 07/14/2021 |
| K132631 | PHADIA US INC. | EIA SMDP IMMUNOASSAY | 08/29/2014 |
| K000312 | PHARMACIA & UPJOHN CO. | VARELISA SM ANTIBODIES | 03/17/2000 |
| K980540 | QUEST INTL., INC. | SERAQUEST ANTI-SM | 06/15/1998 |
| K980811 | QUEST INTL., INC. | SERAQUEST ANTI-SM/RNP | 05/12/1998 |
| K000755 | RHIGENE, INC. | RHIGENE MESACUP2 TEST- SM | 05/09/2000 |
| K042629 | SWEDEN DIAGNOSTICS (GERMANY) GMBH | VARELISA SM ANTIBODIES, MODEL 18296 | 12/08/2004 |
| K051066 | THERATEST LABORATORIES, INC. | THERATEST EL-ANA PROFILES | 10/07/2005 |
| K983420 | ZEUS SCIENTIFIC, INC. | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO | 11/18/1998 |
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