Panels › Hematology › Product code GJA · Class 2
Test, Thrombin Time
Regulation 864.7875
0510(k)s in 12 months (20 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in GJA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio/Data Corp. | 3 | 0 |
| General Diagnostics | 3 | 0 |
| American Bioproducts Co. | 2 | 0 |
| Behring Diagnostics, Inc. | 2 | 0 |
| bioMerieux | 0 | 2 |
| American Dade | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Dade Behring , Inc. | 0 | 1 |
| Haemachem, Inc. | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2017 | Siemens Healthcare Diagnostics BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and
BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time
Terminated |
GJA | K970645 |
| Oct 28, 2004 | bioMerieux Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 Terminated |
GJA | None listed |
| Oct 28, 2004 | bioMerieux MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 Terminated |
GJA | K802117 |
| Oct 5, 2004 | Dade Behring , Inc. BC Thrombin Reagent . Thrombin Time Test Terminated |
GJA | K970645 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.