QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
FDA 510(k) clearance K163525 · decided 2017-09-05
Clearance details
- K-number
- K163525
- Device name
- QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-15
- Decision date
- 2017-09-05
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- DBM
- Device class
- 2
- Regulation number
- 866.5090
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| EUROIMMUN ANTI-M2-3E ELISA (IGG) (K092736) | Euroimmun Us, Inc. | 2010-09-02 |
| QUANTA LITE M2 EP (MIT3) ELISA (K052262) | Inova Diagnostics, Inc. | 2005-10-27 |
| RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (K031308) | Rhigene, Inc. | 2003-09-26 |
| BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (K030238) | The Binding Site, Ltd. | 2003-03-24 |
| ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (K982121) | Trace Scientific , Ltd. | 1998-09-17 |
| VIRGO AMA ELISA KIT (K971909) | Hemagen Diagnostics, Inc. | 1997-06-20 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (K962452) | Hycor Biomedical, Inc. | 1996-11-25 |
| VARELISA M2 ANTIBODIES (K945607) | Elias U.S.A., Inc. | 1995-01-24 |
| MITOCHONDRIA EIA TEST KIT (K940251) | David A. Fuccillo, Ph.D. | 1994-05-03 |
Recalls involving this device
No recalls on record reference this clearance.