Aynelisa M2-ANTIBODIES
FDA 510(k) K930143 · Elias U.S.A., Inc.
510(k) numberK930143
Submission
- Device name
- Aynelisa M2-ANTIBODIES
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- January 12, 1993
- Decision date
- May 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
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|---|---|---|---|
| K181556 | EliA M2 ImmunoassayDBM · Traditional | Phadia AB | 07/13/2018SE |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…DBM · Traditional | Inova Diagnostics, Inc. | 09/05/2017SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | Immco Diagnostics, Inc. | 08/08/2017SE |
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | Phadia US, Inc. | 02/13/2015SE |
| K092736 | Euroimmun ANTI-M2-3E Elisa (Igg)DBM · Traditional | Euroimmun Us, Inc. | 09/02/2010SE |
| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | Inova Diagnostics, Inc. | 10/27/2005SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | Rhigene, Inc. | 09/26/2003SE |
| K030238 | Bindazyme Anti-Mitochondria M2 Iggam Eia KitDBM · Traditional | The Binding Site, Ltd. | 03/24/2003SE |
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | Trace Scientific , Ltd. | 09/17/1998SE |
| K971909 | Virgo Ama Elisa KitDBM · Traditional | Hemagen Diagnostics, Inc. | 06/20/1997SE |
More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964385 | Elias ANA-HEP-2LJM · Traditional | 03/06/1997SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | 09/30/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
Questions and answers
When was Aynelisa M2-ANTIBODIES cleared by the FDA?
Aynelisa M2-ANTIBODIES (K930143) received a 510(k) decision of Substantially Equivalent on May 11, 1993, 119 days after the submission was received.
What is the product code of K930143?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.