510(k) K954723 ยท LKJ Antinuclear Antibody, Antigen, Control
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Dec 15, 1995 |
| Received | Oct 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2011 | Bio-Rad Laboratories Inc DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories. Terminated |
LKJ | None listed |
| Mar 2, 2011 | Bio-Rad Laboratories Inc Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests,
Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA.
Intended to Terminated |
LKJ | None listed |
| Dec 13, 2010 | Bio-Rad Laboratories Inc Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc. Terminated |
LKJ | None listed |
| Dec 13, 2010 | Bio-Rad Laboratories Inc Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test,
Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics. Terminated |
LKJ | None listed |
| Dec 6, 2010 | Bio-Rad Laboratories Inc Autoimmune EIA ANA Screening Test Kit, 96 Tests,
Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA Terminated |
LKJ | None listed |
| Dec 6, 2010 | Bio-Rad Laboratories Inc Autoimmune EIA ANA Screening Test Kit, 576 Tests,
Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA. Terminated |
LKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.