Vacutainer(R) Brand Safety-Lok Blood Collect Set
FDA 510(k) K921636 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK921636
Submission
- Device name
- Vacutainer(R) Brand Safety-Lok Blood Collect Set
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- April 6, 1992
- Decision date
- April 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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|---|---|---|---|
| K240455 | BD Vacutainer® Citrate Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 10/31/2024SE |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…GIM · Traditional | Becton, Dickinson and Company | 11/27/2023SE |
| 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 |
| K951886 | Lok-On Needle Disposal SystemGIM · Traditional | Becton Dickinson Vacutainer Systems | 06/30/1995SE |
| K945458 | Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/06/1995SE |
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Questions and answers
When was Vacutainer(R) Brand Safety-Lok Blood Collect Set cleared by the FDA?
Vacutainer(R) Brand Safety-Lok Blood Collect Set (K921636) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 23 days after the submission was received.
What is the product code of K921636?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.