Panels › Immunology › Product code LLL · Class 2
Extractable Antinuclear Antibody, Antigen And Control
Regulation 866.5100
2510(k)s in 12 months (182 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in LLL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 1994 | K935417 | JO-1 EIA TEST KIT David A. Fuccillo, Ph.D. | LLL |
| Apr 20, 1994 | K935828 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Jan 31, 1994 | K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Dec 21, 1993 | K934053 | QUANTA LITE(TM) HISTONE ELISA Inova Diagnostics, Inc. | LLL |
| Oct 15, 1993 | K932877 | DIASTAT ANTI-CENTROMERE KIT Shield Diagnostics, Ltd., GB | LLL |
| Sep 24, 1993 | K932850 | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN Helix Diagnostics, Inc. | LLL |
| Sep 8, 1993 | K931543 | ENCORE ENA COMBINED EIA Clark Laboratories, Inc. | LLL |
| Aug 5, 1993 | K932419 | ANTI-SS-B/LA ANTIBODY TEST Helix Diagnostics, Inc. | LLL |
| Jul 16, 1993 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT Helix Diagnostics, Inc. | LLL |
| May 19, 1993 | K924952 | ELISA-DOXA COMBI-6 Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924951 | ELISA-DOXA COMBI-4 Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924950 | ELISA-DOXA JO-1 Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924949 | ELISA-DOXA SCL-70 Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924948 | ELISA-DOXA SM/RNP Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924947 | ELISA-DOXA SM Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924946 | ELISA-DOXA SSB Advanced Biological Products, Inc. | LLL |
| May 19, 1993 | K924945 | ELISA-DPXA SSA KIT Advanced Biological Products, Inc. | LLL |
| Apr 6, 1993 | K930417 | SYNELISA SCL-70 ANTIBODIES Elias U.S.A., Inc. | LLL |
| Apr 6, 1993 | K930281 | SYNELISA JO-1 ANTIBODIES Elias U.S.A., Inc. | LLL |
| Mar 26, 1993 | K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. | LLL |
| Mar 23, 1993 | K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. | LLL |
| Mar 4, 1993 | K926562 | QUANTA LITE(TM) JO-1 ELISA KIT Inova Diagnostics, Inc. | LLL |
| Feb 2, 1993 | K925118 | EN TYPING CIE KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. | LLL |
| Dec 29, 1992 | K924262 | ENA SCREENING CIE KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. | LLL |
| Dec 15, 1992 | K924898 | QUANTA LITE(TM) SCL-70 ELISA Inova Diagnostics, Inc. | LLL |
| Dec 1, 1992 | K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL General Biometrics, Inc. | LLL |
| Dec 1, 1992 | K921870 | ENCORE SM/RNP Clark Laboratories, Inc. | LLL |
| Dec 1, 1992 | K921572 | ENCORE SM Clark Laboratories, Inc. | LLL |
| Nov 30, 1992 | K922241 | AUTOZYME Cambridge Life Sciences Plc. | LLL |
| Oct 16, 1992 | K922340 | ENCORE SS-B Clark Laboratories, Inc. | LLL |
| Oct 13, 1992 | K922157 | ENCORE SS-A Clark Laboratories, Inc. | LLL |
| Sep 18, 1992 | K922833 | QUANTA LITE RNP ELISA Inova Diagnostics, Inc. | LLL |
| Sep 18, 1992 | K922832 | QUANTA LITE SS-B ELISA Inova Diagnostics, Inc. | LLL |
| Sep 18, 1992 | K922831 | QUANTA LITE SM ELISA Inova Diagnostics, Inc. | LLL |
| Sep 18, 1992 | K922830 | QUANTA LITE SS-A ELISA Inova Diagnostics, Inc. | LLL |
| Sep 18, 1992 | K922829 | QUANTA LITE ENA ELISA Inova Diagnostics, Inc. | LLL |
| Apr 7, 1992 | K915420 | HEMAGEN ENA [JO-1] KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920386 | ANTI-ENA ANTIBODY TEST KIT Immco Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920385 | ANTI-ENA ANTIBODY TEST (SM) Immco Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920384 | ANIT-ENA ANTIBODY TEST [SS-B (LA)] Immco Diagnostics, Inc. | LLL |
| Mar 30, 1992 | K920383 | ANTI-ENA ANTIBODY TEST [SS-A (RO)] Immco Diagnostics, Inc. | LLL |
| Feb 12, 1992 | K915282 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Dec 20, 1991 | K915234 | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Dec 20, 1991 | K915058 | HEMAGEN ENA SCREENING KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Nov 5, 1991 | K913041 | ANTI-DSDNA ANTIBODY TEST Helix Diagnostics, Inc. | LLL |
| Sep 23, 1991 | K911679 | ANTI-JO-1 MICROASSAY Diamedix Corp. | LLL |
| Mar 6, 1991 | K910232 | HEMAGEN ENA SCREENING KIT Hemagen Diagnostics, Inc. | LLL |
| Sep 5, 1990 | K903898 | QUANTA LITE TM DSDNA Inova Diagnostics, Inc. | LLL |
| Aug 14, 1990 | K903314 | ANTI-SCI-70 ANTIBODY TEST Immco Diagnostics, Inc. | LLL |
| Aug 9, 1990 | K903047 | IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 General Biometrics, Inc. | LLL |
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