Accuclot Thrombin Time Reagent Model A8713/A4589
FDA 510(k) K982209 · Sigma Diagnostics, Inc.
510(k) numberK982209
Submission
- Device name
- Accuclot Thrombin Time Reagent Model A8713/A4589
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- June 23, 1998
- Decision date
- October 15, 1998
- 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 |
|---|---|---|---|
| K050817 | T-TekGJA · Traditional | R2 Diagnostics, Inc. | 12/12/2005SE |
| 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 |
|---|---|---|
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional | 08/30/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Accuclot Thrombin Time Reagent Model A8713/A4589 cleared by the FDA?
Accuclot Thrombin Time Reagent Model A8713/A4589 (K982209) received a 510(k) decision of Substantially Equivalent on October 15, 1998, 114 days after the submission was received.
What is the product code of K982209?
The FDA product code is GJA – Test, Thrombin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7875.