Vacuum Blood Collecting System (Neo-Tube)
FDA 510(k) K861449 · Exel Intl.
510(k) numberK861449
Submission
- Device name
- Vacuum Blood Collecting System (Neo-Tube)
- Applicant
- Exel Intl.
Fort Lauderdale, FL, US - Received
- April 17, 1986
- Decision date
- September 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 08/25/2023SE |
| K162723 | TransFix/EDTA Vacuum Blood Collection TubesGIM · Traditional | Caltag Medsystems, Ltd. | 06/22/2017SE |
| K080552 | Cyto-Chex BCTGIM · Traditional | Streck | 07/31/2008SE |
| K012152 | DS30 Hcy Blood Collection TubesGIM · Traditional | Drew Scientific , Ltd. | 09/18/2001SE |
| K971449 | Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)GIM · Traditional | Becton Dickinson Vacutainer Systems | 06/17/1997SE |
| K971221 | Greiner Vacuette Blood Collection TubeGIM · Traditional | Greiner America, Inc. | 05/02/1997SE |
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| K945458 | Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/06/1995SE |
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| K904685 | Exel Huber Infusion Set Without Injection Site (Y)FPA · Traditional | 11/21/1990SE |
| K903945 | Exel A-V Fistula SetFIE · Traditional | 11/20/1990SE |
| K895770 | Exel Huber Infusion SetFPA · Traditional | 07/19/1990SE |
| K895772 | Exel Indwelling CatheterFDZ · Traditional | 02/16/1990SE |
| K895771 | Exel Spinal NeedlesFMI · Traditional | 02/16/1990SE |
| K895769 | Exel Huber NeedleFMI · Traditional | 02/16/1990SE |
Questions and answers
When was Vacuum Blood Collecting System (Neo-Tube) cleared by the FDA?
Vacuum Blood Collecting System (Neo-Tube) (K861449) received a 510(k) decision of Substantially Equivalent on September 16, 1986, 152 days after the submission was received.
What is the product code of K861449?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.