Panels › Immunology › Product code LJM · Class 2
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation 866.5100
0510(k)s in 12 months (112 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LJM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 1995 | K950716 | THERATEST EL-ANA PROFILES TEST SYSTEM Theratest Laboratories, Inc. | LJM |
| Jul 18, 1995 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT Helix Diagnostics, Inc. | LJM |
| Jul 17, 1995 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT Helix Diagnostics, Inc. | LJM |
| May 15, 1995 | K950110 | MARDX MITOCHONDRIA EIA TEST SYSTEM Hogan & Hartson | LJM |
| May 15, 1995 | K946218 | MARDX ENA EIA TEST SYSTEM Hogan & Hartson | LJM |
| Apr 17, 1995 | K951207 | VARELISA HISTONE ANTIBODIES Elias U.S.A., Inc. | LJM |
| Apr 17, 1995 | K951205 | VARELISA ANA PROFILE Elias U.S.A., Inc. | LJM |
| Apr 17, 1995 | K951186 | VARELISA ANA-4 SCREEN Elias U.S.A., Inc. | LJM |
| Jan 20, 1995 | K943585 | ANTI-HISTONE ANIBODY TEST Immco Diagnostics, Inc. | LJM |
| Dec 22, 1994 | K944173 | VARELISA JO-1 ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944172 | VARELISA SCL-70 ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944171 | VARELISA CENTROMERE ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944170 | VARELISA SM ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944169 | VARELISA RO (SS-A) ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944168 | VARELISA LA (SS-B) ANTIBODIES Elias U.S.A., Inc. | LJM |
| Dec 22, 1994 | K944167 | VARELISA RNP-SM ANTIBODIES Elias U.S.A., Inc. | LJM |
| Jun 30, 1994 | K941509 | RADIAS ANA SCREEN ENZYME IMMUNOASSAY Bio-Rad | LJM |
| Jun 10, 1994 | K941409 | ENA PROFILE-6 ELISA TEST SYSTEM Zeus Scientific, Inc. | LJM |
| Jun 10, 1994 | K941014 | ENA SCREEN ELISA TEST SYSTEM Zeus Scientific, Inc. | LJM |
| Jun 10, 1994 | K940700 | AUTOZYME SCREEN Cambridge Life Sciences Plc., GB | LJM |
| May 2, 1994 | K940253 | HISTONE EIA TEST KIT David A. Fuccillo, Ph.D. | LJM |
| May 2, 1994 | K935416 | RO EIA TEST KIT David A. Fuccillo, Ph.D. | LJM |
| May 2, 1994 | K935415 | RNP EIA TEST KIT David A. Fuccillo, Ph.D. | LJM |
| May 2, 1994 | K935414 | SM EIA TEST KIT David A. Fuccillo, Ph.D. | LJM |
| Mar 25, 1994 | K940641 | ELIAS ANA TOTAL Elias U.S.A., Inc. | LJM |
| Mar 25, 1994 | K935468 | SYNELISA ANA TOTAL Elias U.S.A., Inc. | LJM |
| Dec 15, 1993 | K933267 | AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM Zeus Scientific, Inc. | LJM |
| Dec 3, 1993 | K932206 | SYNELISA ANA PROFILE Elias U.S.A., Inc. | LJM |
| Aug 10, 1993 | K932424 | ANA PROFILE I Apotex Scientific, Inc. | LJM |
| Jun 11, 1993 | K930209 | SYNELISA RO ABS / LA ABS Elias U.S.A., Inc. | LJM |
| Nov 2, 1992 | K924248 | ACCUTEX SLE LATEX TEST J.S. Medical Assoc. | LJM |
| Nov 2, 1992 | K924087 | KALESTAD ANA MICROPLATE EIA Bio-Rad Laboratories, Inc. | LJM |
| Jul 14, 1992 | K920616 | DIASTAT ANTI-HISTONE KIT Shield Diagnostics, Ltd., GB | LJM |
| Mar 17, 1992 | K915272 | HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LJM |
| Jan 15, 1992 | K914853 | ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT Reads Medical Products, Inc. | LJM |
| Jan 25, 1991 | K910033 | UBI MAGIWEL(TM) ANA QUANTITATIVE United Biotech, Inc. | LJM |
| Dec 7, 1990 | K905190 | DIASTAT ENA PROFILE Shield Diagnostics, Ltd., KN | LJM |
| Sep 6, 1990 | K902915 | ANTI-SCI-70 MICROASSAY Diamedix Corp. | LJM |
| Jan 24, 1990 | K900072 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 General Biometrics, Inc. | LJM |
| Dec 5, 1989 | K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 General Biometrics, Inc. | LJM |
| Oct 27, 1989 | K895995 | RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES Lipogen, Inc. | LJM |
| Oct 24, 1989 | K895994 | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES Lipogen, Inc. | LJM |
| Aug 24, 1989 | K894894 | ANTI-SM MICROASSAY Diamedix Corp. | LJM |
| May 9, 1989 | K892421 | MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST Lipogen, Inc. | LJM |
| Mar 11, 1988 | K874195 | LA ANTIBODY TEST KIT Lipogen, Inc. | LJM |
| Feb 10, 1988 | K875246 | LIPOGEN ANA TEST KIT Lipogen, Inc. | LJM |
| Oct 20, 1987 | K872839 | ANTINUCLEAR ANTIBODY TEST Cappel Diagnostics, Inc. | LJM |
| Mar 24, 1987 | K870453 | DS-DNA EIA DIAGNOSTIC KIT Biohytech International, Inc. | LJM |
| Mar 17, 1987 | K870457 | RNP EIA DIAGNOSTIC KIT Biohytech International, Inc. | LJM |
| Mar 17, 1987 | K870456 | DNP EIA DIAGNOSTIC KIT Biohytech International, Inc. | LJM |
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