QUANTA LITE F-ACTIN IGA ELISA
FDA 510(k) clearance K072967 · decided 2008-01-28
Clearance details
- K-number
- K072967
- Device name
- QUANTA LITE F-ACTIN IGA ELISA
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-22
- Decision date
- 2008-01-28
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- MVM
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| IG_PLEX CELIAC DGP PANEL (K140691) | Sqi Diagnostics Systems, Inc. | 2014-11-06 |
| IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA (K123713) | Immco Diagnostics, Inc. | 2013-10-25 |
| BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI (K130053) | Bio-Rad Laboratories, Inc. | 2013-09-19 |
| IGX PLEX CELIAC QUALITATIVE ASSAY (K102490) | Sqi Diagnostics Systems | 2011-06-02 |
| QUANTA FLASH H-TTG IGG (K101644) | Inova Diagnostics, Inc. | 2011-03-23 |
| EU-TTG IGA AND EU-TTG IGG (K102964) | Grifols USA, Inc. | 2011-03-07 |
| QUANTA FLASH H-TTG IGA (K094060) | Inova Diagnostics, Inc. | 2010-10-13 |
| IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA (K091520) | Immco Diagnostics, Inc. | 2010-03-10 |
Recalls involving this device
No recalls on record reference this clearance.