FDA Product Code
FDA Product Code DBM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5090
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181556 | EliA M2 Immunoassay | Phadia AB | 2018-07-13 | Traditional | PDF ↗ |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Inova Diagnostics, Inc. | 2017-09-05 | Traditional | PDF ↗ |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | 2017-08-08 | Traditional | PDF ↗ |
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Phadia US, Inc. | 2015-02-13 | Traditional | PDF ↗ |
| K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) | Euroimmun Us, Inc. | 2010-09-02 | Traditional | PDF ↗ |
| K052262 | QUANTA LITE M2 EP (MIT3) ELISA | Inova Diagnostics, Inc. | 2005-10-27 | Traditional | PDF ↗ |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | Rhigene, Inc. | 2003-09-26 | Traditional | PDF ↗ |
| K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | The Binding Site, Ltd. | 2003-03-24 | Traditional | PDF ↗ |
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Trace Scientific , Ltd. | 1998-09-17 | Traditional | PDF ↗ |
| K971909 | VIRGO AMA ELISA KIT | Hemagen Diagnostics, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | Hycor Biomedical, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K945607 | VARELISA M2 ANTIBODIES | Elias U.S.A., Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K940251 | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-03 | Traditional | PDF ↗ |
| K930143 | AYNELISA M2-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | 1992-06-19 | Traditional | PDF ↗ |
| K843181 | AUTOFLUOR IV SYSTEM | Tech America Diagnostics | 1984-09-17 | Traditional | PDF ↗ |
| K842247 | MELOY AUTOANTIBODY TEST SYS | Meloy Laboratories, Inc. | 1984-06-26 | Traditional | PDF ↗ |
| K831358 | AUTOANTIBODY SCREEN TEST SYSTEM | Zeus Scientific, Inc. | 1983-06-15 | Traditional | PDF ↗ |
| K831100 | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | Medical Diagnostics, Ca. | 1983-05-04 | Traditional | PDF ↗ |
| K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | Immuno-Products Industries | 1981-05-01 | Traditional | PDF ↗ |
| K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE | Kallestad Laboratories, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K802308 | T/K (ATA/AMA) UNIVERSAL BIOPAK | Bioware Products | 1980-12-01 | Traditional | PDF ↗ |
| K800821 | AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY | Calbiochem-Behring Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800229 | IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 | Traditional | PDF ↗ |
| K790295 | TEST KIT, IIF-AMA | Medica Corp. | 1979-05-25 | Traditional | PDF ↗ |
| K771993 | AFT SYSTEM | Calbiochem | 1977-11-02 | Traditional | PDF ↗ |
| K760155 | TEST, (IVDP) MITOCHONDRIAL ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code DBM · Class II · Immunology. Data: openFDA.