Venom Tiem Reagent
FDA 510(k) K955115 · Medical Diagnostic Technologies, Inc.
510(k) numberK955115
Submission
- Device name
- Venom Tiem Reagent
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- November 9, 1995
- Decision date
- April 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JCO – Bothrops Atrox Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8100
- Specialty
- Hematology
Other 510(k)s with product code JCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932787 | Batroxobin ReagentJCO · Traditional | Behring Diagnostics, Inc. | 11/29/1993SE |
| K896033 | FDP Collection TubesJCO · Traditional | Medical Diagnostic Technologies, Inc. | 10/27/1989SE |
| K852519 | Dupont Aca Fibrin Degradation Prod Clotting TubeJCO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/12/1985SE |
| K843207 | Reptilase -PcJCO · Traditional | Bio/Data Corp. | 10/23/1984SE |
| K840210 | Reptilase-R HA35JCO · Traditional | Wellcome Diagnostics | 04/23/1984SE |
| K780355 | AtroxinJCO · Traditional | Sigma Chemical Co. | 04/18/1978SE |
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K062229 | CTC Workstation, Model 2200LLZ · Traditional | 09/11/2006SE |
| K972209 | Spectrolyse Heparin (Anti-Iia)KFF · Traditional | 08/12/1997SE |
| K963106 | Chromolize PAI-1 KitGGP · Traditional | 11/18/1996SE |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | 08/14/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | 07/31/1996SE |
| K960438 | Tintelize PAI-1 KitGGP · Traditional | 06/05/1996SE |
| K961724 | U-Doa ControlsDIF · Traditional | 06/03/1996SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | 05/24/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | 02/29/1996SE |
| K952746 | Alkaline Phosphatase Reagent SystemCJE · Traditional | 11/27/1995SE |
Questions and answers
When was Venom Tiem Reagent cleared by the FDA?
Venom Tiem Reagent (K955115) received a 510(k) decision of Substantially Equivalent on April 3, 1996, 146 days after the submission was received.
What is the product code of K955115?
The FDA product code is JCO – Bothrops Atrox Reagent, a Class II (moderate risk) device regulated under 21 CFR 864.8100.