ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
FDA 510(k) clearance K954723 · decided 1995-12-15
Clearance details
- K-number
- K954723
- Device name
- ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
- Applicant
- Helix Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-13
- Decision date
- 1995-12-15
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LKJ
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- West Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laborato recall (Z-1478-2011) | Bio-Rad Laboratories Inc | 2011-03-02 |
| Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Ma recall (Z-1479-2011) | Bio-Rad Laboratories Inc | 2011-03-02 |
| Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed an recall (Z-0612-2011) | Bio-Rad Laboratories Inc | 2010-12-13 |
| Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactur recall (Z-0613-2011) | Bio-Rad Laboratories Inc | 2010-12-13 |
| Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured b recall (Z-0539-2011) | Bio-Rad Laboratories Inc | 2010-12-06 |
| Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured recall (Z-0540-2011) | Bio-Rad Laboratories Inc | 2010-12-06 |