FDA Product Code
FDA Product Code LLL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 182 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | 2026-08-21 | Traditional | PDF ↗ |
| K253367 | EliA CTD 13 Screen | Phadia AB | 2026-06-25 | Traditional | PDF ↗ |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | 2025-10-22 | Traditional | PDF ↗ |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | 2025-09-19 | Traditional | PDF ↗ |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023-09-29 | Traditional | PDF ↗ |
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | 2019-11-29 | Traditional | PDF ↗ |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | 2018-06-25 | Traditional | PDF ↗ |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Inova Diagnostics, Inc. | 2016-06-01 | Traditional | PDF ↗ |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Inova Diagnostics, Inc. | 2016-02-12 | Traditional | PDF ↗ |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | Immco Diagnostics, Inc. | 2015-03-31 | Traditional | PDF ↗ |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | Inova Diagnostics, Inc. | 2015-02-12 | Traditional | PDF ↗ |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | Inova Diagnostics, Inc. | 2015-01-29 | Traditional | PDF ↗ |
| K122923 | QUANTA FLASH ENA7 | Inova Diagnostics, Inc. | 2013-05-07 | Traditional | PDF ↗ |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Euroimmun US | 2013-04-09 | Traditional | PDF ↗ |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2011-12-02 | Traditional | PDF ↗ |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Biomedical Diagnostics (Bmd) SA | 2010-12-03 | Traditional | PDF ↗ |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Phadia US, Inc. | 2008-01-15 | Traditional | PDF ↗ |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | 2006-03-13 | Traditional | PDF ↗ |
| K050286 | FIDIS CONNECTIVE 8 | Biomedical Diagnostics (Bmd) SA | 2005-10-03 | Traditional | PDF ↗ |
| K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | Bioarray Solutions, Ltd. | 2005-05-31 | Traditional | PDF ↗ |
| K041753 | AESKULISA ENA 6 S | Aesku Diagnostics | 2004-07-14 | Traditional | PDF ↗ |
| K040160 | QUANTA PLEX SLE PROFILE 8 | Inova Diagnostics, Inc. | 2004-03-08 | Traditional | PDF ↗ |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | Rhigene, Inc. | 2003-12-22 | Traditional | PDF ↗ |
| K032469 | AESKULISA ANA 8PRO | Aesku, Inc. | 2003-12-16 | Traditional | PDF ↗ |
| K031450 | QUANTA PLEX ENA PROFILE 6 | Inova Diagnostics, Inc. | 2003-06-25 | Traditional | PDF ↗ |
| K030681 | QUANTA PLEX ENA PROFILE 5 | Inova Diagnostics, Inc. | 2003-04-24 | Traditional | PDF ↗ |
| K011140 | QUANTA PLEX ENA PROFILE 4 | Inova Diagnostics, Inc. | 2001-07-27 | Traditional | PDF ↗ |
| K010147 | ENA EIA KIT | The Binding Site, Ltd. | 2001-03-01 | Traditional | PDF ↗ |
| K010146 | ENA EIA KIT RANGE | The Binding Site, Ltd. | 2001-03-01 | Traditional | PDF ↗ |
| K010148 | ENA SCREEN EIA KIT | The Binding Site, Ltd. | 2001-02-23 | Traditional | PDF ↗ |
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 | Traditional | PDF ↗ |
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 | Traditional | PDF ↗ |
| K000750 | RHIGENE MESACUP2 TEST- SCL-70 | Rhigene, Inc. | 2000-05-09 | Traditional | PDF ↗ |
| K000749 | RHIGENE MESACUP2 TEST- SSA | Rhigene, Inc. | 2000-05-09 | Traditional | PDF ↗ |
| K000751 | RHIGENE MESACUP2 TEST- SSB | Rhigene, Inc. | 2000-05-09 | Traditional | PDF ↗ |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-04-05 | Traditional | PDF ↗ |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | Trinity Biotech USA | 2000-01-12 | Traditional | PDF ↗ |
| K994029 | MDI SM TEST | Micro Detect, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | Micro Detect, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K991657 | QUANTA LITE ANA ELISA | Inova Diagnostics, Inc. | 1999-06-17 | Traditional | PDF ↗ |
| K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K990798 | AUTOSTAT II ANTI-JO-1 ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K990797 | AUTOSTAT II ANTI-SCL-70 ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K983921 | AUTOSTAT II ENA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1998-12-28 | Traditional | PDF ↗ |
| K984462 | LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K983426 | THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983376 | THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983425 | THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983464 | THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983423 | THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K982603 | QUANTA LITE CHROMATIN ELISA | Inova Diagnostics, Inc. | 1998-10-07 | Traditional | PDF ↗ |
| K982150 | EL-ANA PROFILES: EL-ENA/4 | Theratest Laboratories, Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K982622 | EL-ANA PROFILES: EL-ENA/5 | Theratest Laboratories, Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K981857 | QUANTA LITE TPO ELISA | Inova Diagnostics, Inc. | 1998-07-29 | Traditional | PDF ↗ |
| K980639 | SERAQUEST ANTI-SSB | Quest Intl., Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K980759 | DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM | Diamedix Corp. | 1998-04-23 | Traditional | PDF ↗ |
| K970220 | IS-ANTI-SM TEST SYSTEM | Diamedix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K970237 | IS-ANTI-SSB TEST SYSTEM (720-260) | Diamedix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K970228 | IS-ANTI-JO-1 TEST SYSTEM | Diamedix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K964787 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM | Mardx Diagnostics, Inc. | 1997-04-08 | Traditional | PDF ↗ |
| K970238 | IS-ANTI-SM/RNP (720-270) | Diamedix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K970239 | IS-ANTI-SCL-70 TEST SYSTEM (720-280) | Diamedix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K970218 | IS-ANTI-SSA TEST SYSTEM | Diamedix Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962719 | HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962727 | HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-09-13 | Traditional | PDF ↗ |
| K961913 | QUANTA LITE ENA 6 ELISA | Inova Diagnostics, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K955602 | RELSIA SCL-70 ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K955603 | RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K954894 | HYTEC AUTOIMMUNE KITS (SCL-70) | Hycor Biomedical, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K955134 | ORGENTEC ENASCREEN ELISA ASSAY | Orgentec | 1996-03-20 | Traditional | PDF ↗ |
| K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY | Orgentec | 1996-03-20 | Traditional | PDF ↗ |
| K954895 | HYTEC AUTOIMMUNE KIT (JO-1) | Hycor Biomedical, Inc. | 1996-03-20 | Traditional | PDF ↗ |
| K954890 | HYTEC AUTOMMUNE KIT (ENA) | Hycor Biomedical, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | Helix Diagnostics, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K952076 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K952077 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K950414 | HEMAGEN ENA SM/RMP KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K946120 | HEMAGEN ENA SS-B KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K946123 | HEMAGEN ENA SM KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K946124 | HEMAGEN ENA JO-1 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K946122 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K946121 | HEMAGEN ENA SS-A KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K943291 | ANTI DS-DNA | Sigma Diagnostics, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT | Shield Diagnostics, Ltd. | 1994-11-21 | Traditional | PDF ↗ |
| K943076 | QUANTA LITE ENA 5 ELISA KIT | Inova Diagnostics, Inc. | 1994-10-25 | Traditional | PDF ↗ |
| K940362 | ANA SCREEN ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1994-07-28 | Traditional | PDF ↗ |
| K935413 | ENA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-06-02 | Traditional | PDF ↗ |
| K940622 | ELIAS ENA SCREEN (MICROTITER PLATE) | Elias U.S.A., Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K940229 | SYN ENA SCREEN (PIN PLATE) | Elias U.S.A., Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K935417 | JO-1 EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-05 | Traditional | PDF ↗ |
| K935419 | LA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-05 | Traditional | PDF ↗ |
Product code LLL · Class II · Immunology. Data: openFDA.