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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K935418 | SCL-70 EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-05 | Traditional | PDF ↗ |
| K935828 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM | Immuno Concepts, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K934053 | QUANTA LITE(TM) HISTONE ELISA | Inova Diagnostics, Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K932877 | DIASTAT ANTI-CENTROMERE KIT | Shield Diagnostics, Ltd. | 1993-10-15 | Traditional | PDF ↗ |
| K932850 | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN | Helix Diagnostics, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K931543 | ENCORE ENA COMBINED EIA | Clark Laboratories, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K932419 | ANTI-SS-B/LA ANTIBODY TEST | Helix Diagnostics, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1993-07-16 | Traditional | PDF ↗ |
| K924946 | ELISA-DOXA SSB | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924949 | ELISA-DOXA SCL-70 | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924945 | ELISA-DPXA SSA KIT | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924952 | ELISA-DOXA COMBI-6 | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924947 | ELISA-DOXA SM | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924951 | ELISA-DOXA COMBI-4 | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924950 | ELISA-DOXA JO-1 | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K924948 | ELISA-DOXA SM/RNP | Advanced Biological Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K930281 | SYNELISA JO-1 ANTIBODIES | Elias U.S.A., Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K930417 | SYNELISA SCL-70 ANTIBODIES | Elias U.S.A., Inc. | 1993-04-06 | Traditional | PDF ↗ |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | Biowhittaker Molecular Applications, Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT | Biowhittaker Molecular Applications, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K926562 | QUANTA LITE(TM) JO-1 ELISA KIT | Inova Diagnostics, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K925118 | EN TYPING CIE KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-02-02 | Traditional | PDF ↗ |
| K924262 | ENA SCREENING CIE KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1992-12-29 | Traditional | PDF ↗ |
| K924898 | QUANTA LITE(TM) SCL-70 ELISA | Inova Diagnostics, Inc. | 1992-12-15 | Traditional | PDF ↗ |
| K921572 | ENCORE SM | Clark Laboratories, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K921870 | ENCORE SM/RNP | Clark Laboratories, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL | General Biometrics, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K922241 | AUTOZYME | Cambridge Life Sciences Plc. | 1992-11-30 | Traditional | PDF ↗ |
| K922340 | ENCORE SS-B | Clark Laboratories, Inc. | 1992-10-16 | Traditional | PDF ↗ |
| K922157 | ENCORE SS-A | Clark Laboratories, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K922829 | QUANTA LITE ENA ELISA | Inova Diagnostics, Inc. | 1992-09-18 | Traditional | PDF ↗ |
| K922832 | QUANTA LITE SS-B ELISA | Inova Diagnostics, Inc. | 1992-09-18 | Traditional | PDF ↗ |
| K922830 | QUANTA LITE SS-A ELISA | Inova Diagnostics, Inc. | 1992-09-18 | Traditional | PDF ↗ |
| K922831 | QUANTA LITE SM ELISA | Inova Diagnostics, Inc. | 1992-09-18 | Traditional | PDF ↗ |
| K922833 | QUANTA LITE RNP ELISA | Inova Diagnostics, Inc. | 1992-09-18 | Traditional | PDF ↗ |
| K915420 | HEMAGEN ENA [JO-1] KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1992-04-07 | Traditional | PDF ↗ |
| K920384 | ANIT-ENA ANTIBODY TEST [SS-B (LA)] | Immco Diagnostics, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K920383 | ANTI-ENA ANTIBODY TEST [SS-A (RO)] | Immco Diagnostics, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K920386 | ANTI-ENA ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K920385 | ANTI-ENA ANTIBODY TEST (SM) | Immco Diagnostics, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K915282 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1992-02-12 | Traditional | PDF ↗ |
| K915058 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K915234 | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K913041 | ANTI-DSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K911679 | ANTI-JO-1 MICROASSAY | Diamedix Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K910232 | HEMAGEN ENA SCREENING KIT | Hemagen Diagnostics, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K903898 | QUANTA LITE TM DSDNA | Inova Diagnostics, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K903314 | ANTI-SCI-70 ANTIBODY TEST | Immco Diagnostics, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K902938 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 | General Biometrics, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K903047 | IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 | General Biometrics, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K901924 | READS(R) ANTI-ENA (SM/RNP) TEST KIT | Biosearch Medical Products, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K901230 | REAADS ANTI-SM TEST KIT | Biosearch Medical Products, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K901073 | ANTI-RNP MICROASSAY | Diamedix Corp. | 1990-03-19 | Traditional | PDF ↗ |
| K900617 | SERATEST ENA [SSA] KIT | Hemagen Diagnostics, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K900241 | ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY | Diamedix Corp. | 1990-02-02 | Traditional | PDF ↗ |
| K896460 | NOVA GEL(TM) T SS-A/SS-B | Inova Diagnostics, Inc. | 1989-11-20 | Traditional | PDF ↗ |
| K896461 | NOVA GEL(TM) T SCL-70 | Inova Diagnostics, Inc. | 1989-11-20 | Traditional | PDF ↗ |
| K896462 | NOVA GEL(TM) T JO-1 | Inova Diagnostics, Inc. | 1989-11-20 | Traditional | PDF ↗ |
| K896459 | NOVA GEL(TM) T SM/RNP | Inova Diagnostics, Inc. | 1989-11-20 | Traditional | PDF ↗ |
| K895339 | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST | Immco Diagnostics, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K892897 | NOVA GEL(TM) JO-1 | Inova Diagnostics, Inc. | 1989-05-17 | Traditional | PDF ↗ |
| K881341 | NOVA LITE(TM) SA | Inova Diagnostics, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K883232 | HISTONE REACTIVE ANA | Val Tech Diagnostics, Inc. | 1988-09-07 | Traditional | PDF ↗ |
| K881340 | NOVA LITE(TM) AUTOANTIBODY CONTROLS | Inova Diagnostics, Inc. | 1988-06-08 | Traditional | PDF ↗ |
| K881339 | NOVA LITE(TM) ANA PLUS | Inova Diagnostics, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K880897 | NOVA GEL (TM) SCL-70 | Inova Diagnostics, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K881181 | NOVA GEL(TM) SM/RNP | Inova Diagnostics, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K880896 | NOVA GEL(TM) SS-A/SS-B | Inova Diagnostics, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K880736 | NOVA LITE(TM) ANA | Inova Diagnostics, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K873708 | FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES | Whittaker Bioproducts, Inc. | 1987-11-25 | Traditional | PDF ↗ |
| K871994 | ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) | Behring Diagnostics, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K862700 | SERATEST ENA [SS-B] KIT | Hemagen Diagnostics, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | Kallestad Laboratories, Inc. | 1986-07-29 | Traditional | PDF ↗ |
| K860428 | SM-RNP AUTOANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1986-05-15 | Traditional | PDF ↗ |
| K860644 | SS-A/SS-B AUTOANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1986-03-28 | Traditional | PDF ↗ |
| K843423 | PHYSIO GAS ANALYZER | Research Medical, Inc. | 1985-02-26 | Traditional | PDF ↗ |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | Seragen Diagnostics, Inc. | 1985-02-04 | Traditional | PDF ↗ |
| K843978 | ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY | Behring Diagnostics, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K840221 | EXTRACTABLE NUCLEAR ANTIGEN ASSAY | Zeus Scientific, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | Calbiochem-Behring Corp. | 1983-04-27 | Traditional | PDF ↗ |
| K810592 | NUCLEAR ANTIGENS | Alpha Antigens, Inc. | 1981-10-23 | Traditional | PDF ↗ |
Product code LLL · Class II · Immunology. Data: openFDA.