Product Code: LLL
FDA class 2
21 CFR 866.5100
Extractable Antinuclear Antibody, Antigen And Control
Immunology
Extractable Antinuclear Antibody, Antigen and Control is a diagnostic immunoassay system used to detect antibodies against extractable nuclear antigens (ENAs), a group of nuclear proteins associated with specific autoimmune diseases such as Sjogren's syndrome, mixed connective tissue disease, scleroderma, and polymyositis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLL, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
180
FEI Numbers
25
Registration Numbers
25
Unique Applicants
44
Years Active
44
Research product code LLL in seconds
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Basic Information
- Product Code
- LLL
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 180 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250666 | Alegria Flash CTD Screen | Oct 22, 2025 | Substantially Equivalent | Zeus Scientific |
| K250408 | Alegria Flash ENA Screen | Sep 19, 2025 | Substantially Equivalent | Zeus Scientific |
| K213403 | Aptiva CTD Essential Reagent | Sep 29, 2023 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K190710 | EliA SymphonyS Immunoassay | Nov 29, 2019 | Substantially Equivalent | Phadia AB |
| K180975 | QUANTA Flash HMGCR Reagents | Jun 25, 2018 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Jun 01, 2016 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Feb 12, 2016 | Substantially Equivalent | Inova Diagnostics, Inc. |
| 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 | Mar 31, 2015 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | Feb 12, 2015 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | Jan 29, 2015 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K122923 | QUANTA FLASH ENA7 | May 07, 2013 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Apr 09, 2013 | Substantially Equivalent | Euroimmun US |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Dec 02, 2011 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Dec 03, 2010 | Substantially Equivalent | Biomedical Diagnostics (Bmd) SA |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Jan 15, 2008 | Substantially Equivalent | Phadia US, Inc. |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | Mar 13, 2006 | Substantially Equivalent | Biomedical Diagnostics (Bmd) SA |
| K050286 | FIDIS CONNECTIVE 8 | Oct 03, 2005 | Substantially Equivalent | Biomedical Diagnostics (Bmd) SA |
| K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | May 31, 2005 | Substantially Equivalent | Bioarray Solutions, Ltd. |
| K041753 | AESKULISA ENA 6 S | Jul 14, 2004 | Substantially Equivalent | Aesku Diagnostics |
| K040160 | QUANTA PLEX SLE PROFILE 8 | Mar 08, 2004 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | Dec 22, 2003 | Substantially Equivalent | Rhigene, Inc. |
| K032469 | AESKULISA ANA 8PRO | Dec 16, 2003 | Substantially Equivalent | Aesku, Inc. |
| K031450 | QUANTA PLEX ENA PROFILE 6 | Jun 25, 2003 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K030681 | QUANTA PLEX ENA PROFILE 5 | Apr 24, 2003 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K011140 | QUANTA PLEX ENA PROFILE 4 | Jul 27, 2001 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K010147 | ENA EIA KIT | Mar 01, 2001 | Substantially Equivalent | The Binding Site, Ltd. |
| K010146 | ENA EIA KIT RANGE | Mar 01, 2001 | Substantially Equivalent | The Binding Site, Ltd. |
| K010148 | ENA SCREEN EIA KIT | Feb 23, 2001 | Substantially Equivalent | The Binding Site, Ltd. |
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | Oct 13, 2000 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | Oct 13, 2000 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K000751 | RHIGENE MESACUP2 TEST- SSB | May 09, 2000 | Substantially Equivalent | Rhigene, Inc. |
| K000750 | RHIGENE MESACUP2 TEST- SCL-70 | May 09, 2000 | Substantially Equivalent | Rhigene, Inc. |
| K000749 | RHIGENE MESACUP2 TEST- SSA | May 09, 2000 | Substantially Equivalent | Rhigene, Inc. |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | Apr 05, 2000 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | Jan 12, 2000 | Substantially Equivalent | Trinity Biotech USA |
| K994029 | MDI SM TEST | Jan 11, 2000 | Substantially Equivalent | Micro Detect, Inc. |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | Jan 11, 2000 | Substantially Equivalent | Micro Detect, Inc. |
| K991657 | QUANTA LITE ANA ELISA | Jun 17, 1999 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K990798 | AUTOSTAT II ANTI-JO-1 ELISA | Apr 28, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K990797 | AUTOSTAT II ANTI-SCL-70 ELISA | Apr 28, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA | Apr 28, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA | Apr 28, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K983921 | AUTOSTAT II ENA SCREEN ELISA | Dec 28, 1998 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K984462 | LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 | Dec 22, 1998 | Substantially Equivalent | Bio-Rad |
| K983464 | THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Nov 18, 1998 | Substantially Equivalent | Zeus Scientific, Inc. |
| K983426 | THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC | Nov 18, 1998 | Substantially Equivalent | Zeus Scientific, Inc. |
| K983425 | THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET | Nov 18, 1998 | Substantially Equivalent | Zeus Scientific, Inc. |
| K983423 | THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Nov 18, 1998 | Substantially Equivalent | Zeus Scientific, Inc. |
| K983376 | THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S | Nov 18, 1998 | Substantially Equivalent | Zeus Scientific, Inc. |
| K982603 | QUANTA LITE CHROMATIN ELISA | Oct 07, 1998 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K982622 | EL-ANA PROFILES: EL-ENA/5 | Aug 13, 1998 | Substantially Equivalent | Theratest Laboratories, Inc. |
| K982150 | EL-ANA PROFILES: EL-ENA/4 | Aug 13, 1998 | Substantially Equivalent | Theratest Laboratories, Inc. |
| K981857 | QUANTA LITE TPO ELISA | Jul 29, 1998 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K980639 | SERAQUEST ANTI-SSB | Jun 15, 1998 | Substantially Equivalent | Quest Intl., Inc. |
| K980759 | DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM | Apr 23, 1998 | Substantially Equivalent | Diamedix Corp. |
| K970239 | IS-ANTI-SCL-70 TEST SYSTEM (720-280) | Apr 08, 1997 | Substantially Equivalent | Diamedix Corp. |
| K970238 | IS-ANTI-SM/RNP (720-270) | Apr 08, 1997 | Substantially Equivalent | Diamedix Corp. |
| K970237 | IS-ANTI-SSB TEST SYSTEM (720-260) | Apr 08, 1997 | Substantially Equivalent | Diamedix Corp. |
| K970228 | IS-ANTI-JO-1 TEST SYSTEM | Apr 08, 1997 | Substantially Equivalent | Diamedix Corp. |
| K970220 | IS-ANTI-SM TEST SYSTEM | Apr 08, 1997 | Substantially Equivalent | Diamedix Corp. |
| K970218 | IS-ANTI-SSA TEST SYSTEM | Apr 08, 1997 | Substantially Equivalent | Diamedix Corp. |
| K964787 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM | Apr 08, 1997 | Substantially Equivalent | Mardx Diagnostics, Inc. |
| K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K962727 | HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K962719 | HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY | Mar 07, 1997 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | Sep 13, 1996 | Substantially Equivalent | Immuno Concepts, Inc. |
| K961913 | QUANTA LITE ENA 6 ELISA | Jul 10, 1996 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM | Apr 19, 1996 | Substantially Equivalent | Immuno Concepts, Inc. |
| K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM | Apr 19, 1996 | Substantially Equivalent | Immuno Concepts, Inc. |
| K955603 | RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM | Apr 19, 1996 | Substantially Equivalent | Immuno Concepts, Inc. |
| K955602 | RELSIA SCL-70 ANTIBODY TEST SYSTEM | Apr 19, 1996 | Substantially Equivalent | Immuno Concepts, Inc. |
| K955134 | ORGENTEC ENASCREEN ELISA ASSAY | Mar 20, 1996 | Substantially Equivalent | Orgentec |
| K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY | Mar 20, 1996 | Substantially Equivalent | Orgentec |
| K954895 | HYTEC AUTOIMMUNE KIT (JO-1) | Mar 20, 1996 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K954894 | HYTEC AUTOIMMUNE KITS (SCL-70) | Mar 20, 1996 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K954890 | HYTEC AUTOMMUNE KIT (ENA) | Dec 26, 1995 | Substantially Equivalent | Hycor Biomedical, Inc. |
| K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | Aug 24, 1995 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K952077 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | Jun 05, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K952076 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | Jun 05, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K950414 | HEMAGEN ENA SM/RMP KIT (EIA METHOD) | Mar 29, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K946124 | HEMAGEN ENA JO-1 KIT (EIA METHOD) | Feb 22, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K946123 | HEMAGEN ENA SM KIT (EIA METHOD) | Feb 22, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K946122 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | Feb 22, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K946121 | HEMAGEN ENA SS-A KIT (EIA METHOD) | Feb 22, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K946120 | HEMAGEN ENA SS-B KIT (EIA METHOD) | Feb 22, 1995 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K943291 | ANTI DS-DNA | Dec 02, 1994 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT | Nov 21, 1994 | Substantially Equivalent | Shield Diagnostics, Ltd. |
| K943076 | QUANTA LITE ENA 5 ELISA KIT | Oct 25, 1994 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K940362 | ANA SCREEN ELISA TEST SYSTEM | Jul 28, 1994 | Substantially Equivalent | Zeus Scientific, Inc. |
| K935413 | ENA EIA TEST KIT | Jun 02, 1994 | Substantially Equivalent | David A. Fuccillo, Ph.D. |
| K940622 | ELIAS ENA SCREEN (MICROTITER PLATE) | May 11, 1994 | Substantially Equivalent | Elias U.S.A., Inc. |
| K940229 | SYN ENA SCREEN (PIN PLATE) | May 11, 1994 | Substantially Equivalent | Elias U.S.A., Inc. |
| K935419 | LA EIA TEST KIT | May 05, 1994 | Substantially Equivalent | David A. Fuccillo, Ph.D. |
| K935418 | SCL-70 EIA TEST KIT | May 05, 1994 | Substantially Equivalent | David A. Fuccillo, Ph.D. |
| K935417 | JO-1 EIA TEST KIT | May 05, 1994 | Substantially Equivalent | David A. Fuccillo, Ph.D. |
| K935828 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | Apr 20, 1994 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM | Jan 31, 1994 | Substantially Equivalent | Immuno Concepts, Inc. |
| K934053 | QUANTA LITE(TM) HISTONE ELISA | Dec 21, 1993 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K932877 | DIASTAT ANTI-CENTROMERE KIT | Oct 15, 1993 | Substantially Equivalent | Shield Diagnostics, Ltd. |
| K932850 | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN | Sep 24, 1993 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K931543 | ENCORE ENA COMBINED EIA | Sep 08, 1993 | Substantially Equivalent | Clark Laboratories, Inc. |
| K932419 | ANTI-SS-B/LA ANTIBODY TEST | Aug 05, 1993 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | Jul 16, 1993 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K924952 | ELISA-DOXA COMBI-6 | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924951 | ELISA-DOXA COMBI-4 | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924950 | ELISA-DOXA JO-1 | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924949 | ELISA-DOXA SCL-70 | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924948 | ELISA-DOXA SM/RNP | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924947 | ELISA-DOXA SM | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924946 | ELISA-DOXA SSB | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K924945 | ELISA-DPXA SSA KIT | May 19, 1993 | Substantially Equivalent | Advanced Biological Products, Inc. |
| K930417 | SYNELISA SCL-70 ANTIBODIES | Apr 06, 1993 | Substantially Equivalent | Elias U.S.A., Inc. |
| K930281 | SYNELISA JO-1 ANTIBODIES | Apr 06, 1993 | Substantially Equivalent | Elias U.S.A., Inc. |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | Mar 26, 1993 | Substantially Equivalent | Biowhittaker Molecular Applications, Inc. |
| K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT | Mar 23, 1993 | Substantially Equivalent | Biowhittaker Molecular Applications, Inc. |
| K926562 | QUANTA LITE(TM) JO-1 ELISA KIT | Mar 04, 1993 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K925118 | EN TYPING CIE KIT FOR DIAGNOSTIC USE | Feb 02, 1993 | Substantially Equivalent | The Binding Site, Ltd. |
| K924262 | ENA SCREENING CIE KIT FOR DIAGNOSTIC USE | Dec 29, 1992 | Substantially Equivalent | The Binding Site, Ltd. |
| K924898 | QUANTA LITE(TM) SCL-70 ELISA | Dec 15, 1992 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL | Dec 01, 1992 | Substantially Equivalent | General Biometrics, Inc. |
| K921870 | ENCORE SM/RNP | Dec 01, 1992 | Substantially Equivalent | Clark Laboratories, Inc. |
| K921572 | ENCORE SM | Dec 01, 1992 | Substantially Equivalent | Clark Laboratories, Inc. |
| K922241 | AUTOZYME | Nov 30, 1992 | Substantially Equivalent | Cambridge Life Sciences Plc. |
| K922340 | ENCORE SS-B | Oct 16, 1992 | Substantially Equivalent | Clark Laboratories, Inc. |
| K922157 | ENCORE SS-A | Oct 13, 1992 | Substantially Equivalent | Clark Laboratories, Inc. |
| K922833 | QUANTA LITE RNP ELISA | Sep 18, 1992 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K922832 | QUANTA LITE SS-B ELISA | Sep 18, 1992 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K922831 | QUANTA LITE SM ELISA | Sep 18, 1992 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K922830 | QUANTA LITE SS-A ELISA | Sep 18, 1992 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K922829 | QUANTA LITE ENA ELISA | Sep 18, 1992 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K915420 | HEMAGEN ENA [JO-1] KIT (EIA METHOD) | Apr 07, 1992 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K920386 | ANTI-ENA ANTIBODY TEST KIT | Mar 30, 1992 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K920385 | ANTI-ENA ANTIBODY TEST (SM) | Mar 30, 1992 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K920384 | ANIT-ENA ANTIBODY TEST [SS-B (LA)] | Mar 30, 1992 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K920383 | ANTI-ENA ANTIBODY TEST [SS-A (RO)] | Mar 30, 1992 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K915282 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | Feb 12, 1992 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K915234 | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) | Dec 20, 1991 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K915058 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | Dec 20, 1991 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K913041 | ANTI-DSDNA ANTIBODY TEST | Nov 05, 1991 | Substantially Equivalent | Helix Diagnostics, Inc. |
| K911679 | ANTI-JO-1 MICROASSAY | Sep 23, 1991 | Substantially Equivalent | Diamedix Corp. |
| K910232 | HEMAGEN ENA SCREENING KIT | Mar 06, 1991 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K903898 | QUANTA LITE TM DSDNA | Sep 05, 1990 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K903314 | ANTI-SCI-70 ANTIBODY TEST | Aug 14, 1990 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K903047 | IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 | Aug 09, 1990 | Substantially Equivalent | General Biometrics, Inc. |
| K902938 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 | Aug 09, 1990 | Substantially Equivalent | General Biometrics, Inc. |
| K901924 | READS(R) ANTI-ENA (SM/RNP) TEST KIT | May 09, 1990 | Substantially Equivalent | Biosearch Medical Products, Inc. |
| K901230 | REAADS ANTI-SM TEST KIT | Mar 23, 1990 | Substantially Equivalent | Biosearch Medical Products, Inc. |
| K901073 | ANTI-RNP MICROASSAY | Mar 19, 1990 | Substantially Equivalent | Diamedix Corp. |
| K900617 | SERATEST ENA [SSA] KIT | Feb 23, 1990 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K900241 | ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY | Feb 02, 1990 | Substantially Equivalent | Diamedix Corp. |
| K896462 | NOVA GEL(TM) T JO-1 | Nov 20, 1989 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K896461 | NOVA GEL(TM) T SCL-70 | Nov 20, 1989 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K896460 | NOVA GEL(TM) T SS-A/SS-B | Nov 20, 1989 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K896459 | NOVA GEL(TM) T SM/RNP | Nov 20, 1989 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K895339 | ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST | Oct 04, 1989 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K892897 | NOVA GEL(TM) JO-1 | May 17, 1989 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K881341 | NOVA LITE(TM) SA | Sep 22, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K883232 | HISTONE REACTIVE ANA | Sep 07, 1988 | Substantially Equivalent | Val Tech Diagnostics, Inc. |
| K881340 | NOVA LITE(TM) AUTOANTIBODY CONTROLS | Jun 08, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K881339 | NOVA LITE(TM) ANA PLUS | Apr 21, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K880897 | NOVA GEL (TM) SCL-70 | Apr 21, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K881181 | NOVA GEL(TM) SM/RNP | Apr 06, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K880896 | NOVA GEL(TM) SS-A/SS-B | Mar 25, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K880736 | NOVA LITE(TM) ANA | Mar 25, 1988 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K873708 | FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES | Nov 25, 1987 | Substantially Equivalent | Whittaker Bioproducts, Inc. |
| K871994 | ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) | Aug 12, 1987 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K862700 | SERATEST ENA [SS-B] KIT | Aug 19, 1986 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | Jul 29, 1986 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K860428 | SM-RNP AUTOANTIBODY TEST SYSTEM | May 15, 1986 | Substantially Equivalent | Immuno Concepts, Inc. |
| K860644 | SS-A/SS-B AUTOANTIBODY TEST SYSTEM | Mar 28, 1986 | Substantially Equivalent | Immuno Concepts, Inc. |
| K843423 | PHYSIO GAS ANALYZER | Feb 26, 1985 | Substantially Equivalent | Research Medical, Inc. |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | Feb 04, 1985 | Substantially Equivalent | Seragen Diagnostics, Inc. |
| K843978 | ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY | Dec 18, 1984 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K840221 | EXTRACTABLE NUCLEAR ANTIGEN ASSAY | May 22, 1984 | Substantially Equivalent | Zeus Scientific, Inc. |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | Apr 27, 1983 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K810592 | NUCLEAR ANTIGENS | Oct 23, 1981 | Substantially Equivalent | Alpha Antigens, Inc. |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.