T-Tek
FDA 510(k) K050817 · R2 Diagnostics, Inc.
510(k) numberK050817
Submission
- Device name
- T-Tek
- Applicant
- R2 Diagnostics, Inc.
South Bend, IN, US - Received
- March 31, 2005
- Decision date
- December 12, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJA – Test, Thrombin Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7875
- Specialty
- Hematology
Other 510(k)s with product code GJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K982209 | Accuclot Thrombin Time Reagent Model A8713/A4589GJA · Traditional | Sigma Diagnostics, Inc. | 10/15/1998SE |
| K970645 | BC Thrombin ReagentGJA · Traditional | Behring Diagnostics, Inc. | 05/19/1997SE |
| K925493 | Biomerieux Hemolab Thrombicalci-TestGJA · Traditional | Biomerieux Vitek, Inc. | 04/21/1994SE |
| K930157 | Test ThrombinGJA · Traditional | Behring Diagnostics, Inc. | 05/14/1993SE |
| K923220 | Thrombin Clot Time Test ProcedureGJA · Traditional | Medical Laboratory Automation Systems, Inc. | 09/29/1992SE |
| K920147 | Thrombin Clotting Time ReagentGJA · Traditional | Helena Laboratories | 05/01/1992SE |
| K900126 | TT and HNTT by HemochronGJA · Traditional | International Technidyne Corp. | 02/05/1990SE |
| K894467 | Thrombin Time ReagentGJA · Traditional | Sigma Chemical Co. | 09/05/1989SE |
| K884385 | Fibri-Prest/Thrombin-Prest ControlsGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
| K884384 | Thrombin-Prest Reagent KitGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
More from American Bioproducts Co.
| 510(k) | Device | Decision |
|---|---|---|
| K102908 | Nofact IxGJT · Traditional | 12/19/2011SE |
| K102851 | Nofact ViiiGJT · Traditional | 12/19/2011SE |
| K090105 | Lupotek KCTGGW · Traditional | 12/30/2010SE |
| K083878 | Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon laGIR · Traditional | 06/25/2010SE |
| K082631 | Thrombo Tek Pse, Model 90-480GGP · Traditional | 12/17/2008SE |
| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional | 03/16/2007SE |
| K042919 | Fibrotek FibGIS · Traditional | 11/29/2004SE |
| K040296 | Phosphoplastin RLGJS · Traditional | 05/24/2004SE |
| K033471 | Phospholin Es and Calcium ChlorideGGW · Traditional | 02/04/2004SE |
Questions and answers
When was T-Tek cleared by the FDA?
T-Tek (K050817) received a 510(k) decision of Substantially Equivalent on December 12, 2005, 256 days after the submission was received.
What is the product code of K050817?
The FDA product code is GJA – Test, Thrombin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7875.