Company ยท US
Genetic Testing Institute
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2008. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2008 | K082205 | FACTOR VIII ANTIBODY SCREEN Genetic Testing Institute | GGP |
| Dec 19, 2007 | K071781 | PF4 IGG Genetic Testing Institute | LCO |
| Jan 20, 2006 | K053559 | PF4 ENHANCED SOLID PHASE ELISA Genetic Testing Institute | LCO |
| Feb 1, 2000 | K993553 | GTI-FVIII INHIBITOR ASSAY Genetic Testing Institute | GGP |
| Mar 9, 1999 | K983379 | GTI-PF4 ELISA Genetic Testing Institute | LCO |
| Jun 14, 1984 | K841114 | ALLO-TYPE HUMAN IMMUNOGLOBULIN- Genetic Testing Institute | DGX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2015 | Genetic Testing Institute,inc PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and
2. ImmucorGamma LIFECODES PF4 Enhanced (catalo Terminated |
LCO | K053559 |
| Mar 28, 2013 | Genetic Testing Institute,inc Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45
GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). Terminated |
LCO | K053559 |