Thrombin Time Reagent
FDA 510(k) K894467 · Sigma Chemical Co.
510(k) numberK894467
Submission
- Device name
- Thrombin Time Reagent
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- July 18, 1989
- Decision date
- September 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| 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 |
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| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Thrombin Time Reagent cleared by the FDA?
Thrombin Time Reagent (K894467) received a 510(k) decision of Substantially Equivalent on September 5, 1989, 49 days after the submission was received.
What is the product code of K894467?
The FDA product code is GJA – Test, Thrombin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7875.