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 |
|---|---|---|---|
| Nov 18, 1998 | K983376 | THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S Zeus Scientific, Inc. | LLL |
| Oct 7, 1998 | K982603 | QUANTA LITE CHROMATIN ELISA Inova Diagnostics, Inc. | LLL |
| Aug 13, 1998 | K982622 | EL-ANA PROFILES: EL-ENA/5 Theratest Laboratories, Inc. | LLL |
| Aug 13, 1998 | K982150 | EL-ANA PROFILES: EL-ENA/4 Theratest Laboratories, Inc. | LLL |
| Jul 29, 1998 | K981857 | QUANTA LITE TPO ELISA Inova Diagnostics, Inc. | LLL |
| Jun 15, 1998 | K980639 | SERAQUEST ANTI-SSB Quest Intl., Inc. | LLL |
| Apr 23, 1998 | K980759 | DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM Diamedix Corp. | LLL |
| Apr 8, 1997 | K970239 | IS-ANTI-SCL-70 TEST SYSTEM (720-280) Diamedix Corp. | LLL |
| Apr 8, 1997 | K970238 | IS-ANTI-SM/RNP (720-270) Diamedix Corp. | LLL |
| Apr 8, 1997 | K970237 | IS-ANTI-SSB TEST SYSTEM (720-260) Diamedix Corp. | LLL |
| Apr 8, 1997 | K970228 | IS-ANTI-JO-1 TEST SYSTEM Diamedix Corp. | LLL |
| Apr 8, 1997 | K970220 | IS-ANTI-SM TEST SYSTEM Diamedix Corp. | LLL |
| Apr 8, 1997 | K970218 | IS-ANTI-SSA TEST SYSTEM Diamedix Corp. | LLL |
| Apr 8, 1997 | K964787 | MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM Mardx Diagnostics, Inc. | LLL |
| Mar 7, 1997 | K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962727 | HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962719 | HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Sep 13, 1996 | K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Jul 10, 1996 | K961913 | QUANTA LITE ENA 6 ELISA Inova Diagnostics, Inc. | LLL |
| Apr 19, 1996 | K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955603 | RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Apr 19, 1996 | K955602 | RELSIA SCL-70 ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | LLL |
| Mar 20, 1996 | K955134 | ORGENTEC ENASCREEN ELISA ASSAY Orgentec | LLL |
| Mar 20, 1996 | K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY Orgentec | LLL |
| Mar 20, 1996 | K954895 | HYTEC AUTOIMMUNE KIT (JO-1) Hycor Biomedical, Inc. | LLL |
| Mar 20, 1996 | K954894 | HYTEC AUTOIMMUNE KITS (SCL-70) Hycor Biomedical, Inc. | LLL |
| Dec 26, 1995 | K954890 | HYTEC AUTOMMUNE KIT (ENA) Hycor Biomedical, Inc. | LLL |
| Aug 24, 1995 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT Helix Diagnostics, Inc. | LLL |
| Jun 5, 1995 | K952077 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Jun 5, 1995 | K952076 | HEMAGEN ENA SCREENING KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Mar 29, 1995 | K950414 | HEMAGEN ENA SM/RMP KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946124 | HEMAGEN ENA JO-1 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946123 | HEMAGEN ENA SM KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946122 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946121 | HEMAGEN ENA SS-A KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946120 | HEMAGEN ENA SS-B KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Dec 2, 1994 | K943291 | ANTI DS-DNA Sigma Diagnostics, Inc. | LLL |
| Nov 21, 1994 | K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT Shield Diagnostics, Ltd., GB | LLL |
| Oct 25, 1994 | K943076 | QUANTA LITE ENA 5 ELISA KIT Inova Diagnostics, Inc. | LLL |
| Jul 28, 1994 | K940362 | ANA SCREEN ELISA TEST SYSTEM Zeus Scientific, Inc. | LLL |
| Jun 2, 1994 | K935413 | ENA EIA TEST KIT David A. Fuccillo, Ph.D. | LLL |
| May 11, 1994 | K940622 | ELIAS ENA SCREEN (MICROTITER PLATE) Elias U.S.A., Inc. | LLL |
| May 11, 1994 | K940229 | SYN ENA SCREEN (PIN PLATE) Elias U.S.A., Inc. | LLL |
| May 5, 1994 | K935419 | LA EIA TEST KIT David A. Fuccillo, Ph.D. | LLL |
| May 5, 1994 | K935418 | SCL-70 EIA TEST KIT David A. Fuccillo, Ph.D. | LLL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.