FDA Product Code
FDA Product Code LKP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202067 | EliA SmDP-S | Phadia AB | 2021-07-14 | Traditional | PDF ↗ |
| K183007 | EliA SmDP Immunoassay | Phadia AB | 2018-12-24 | Traditional | PDF ↗ |
| K132631 | EIA SMDP IMMUNOASSAY | Phadia US, Inc. | 2014-08-29 | Traditional | PDF ↗ |
| K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | Inova Diagnostics, Inc. | 2013-04-17 | Traditional | PDF ↗ |
| K051066 | THERATEST EL-ANA PROFILES | Theratest Laboratories, Inc. | 2005-10-07 | Traditional | PDF ↗ |
| K042629 | VARELISA SM ANTIBODIES, MODEL 18296 | Sweden Diagnostics (Germany) GmbH | 2004-12-08 | Traditional | PDF ↗ |
| K024219 | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST | Fred Hutchinson Cancer Research Center | 2002-07-29 | Traditional | PDF ↗ |
| K000755 | RHIGENE MESACUP2 TEST- SM | Rhigene, Inc. | 2000-05-09 | Traditional | PDF ↗ |
| K000312 | VARELISA SM ANTIBODIES | Pharmacia & Upjohn Co. | 2000-03-17 | Traditional | PDF ↗ |
| K990625 | AUTOSTAT II ANTI-SM ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K984479 | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K983420 | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K980540 | SERAQUEST ANTI-SM | Quest Intl., Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K980811 | SERAQUEST ANTI-SM/RNP | Quest Intl., Inc. | 1998-05-12 | Traditional | PDF ↗ |
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | Orgentec | 1996-05-08 | Traditional | PDF ↗ |
| K954896 | HYTEC AUTOIMMUNE KITS (SM) | Hycor Biomedical, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K930141 | SYNELISA SM ABS/RNP-SM ABS | Elias U.S.A., Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | General Biometrics, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K905191 | DIASTAT ANTI-SM | Shield Diagnostics, Ltd. | 1990-12-07 | Traditional | PDF ↗ |
| K905192 | DIASTAT ANTI-SM/RNP | Shield Diagnostics, Ltd. | 1990-12-07 | Traditional | PDF ↗ |
| K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES | Lipogen, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K881379 | WESBLOT RNP-SM TEST | American Bionetics, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K880254 | SM ANTIBODY TEST KIT | Lipogen, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K873741 | IMMUSTRIP(TM) SM ELISA TEST SYSTEM | Immunomedics, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K841930 | ENZYMATIC ACETAMINOPHEN ASSAY | Diagnostic Chemicals, Ltd. (Usa) | 1984-06-25 | Traditional | PDF ↗ |
Product code LKP · Class II · Immunology. Data: openFDA.