Microtainer Brand Tube with Edta
FDA 510(k) K931368 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK931368
Submission
- Device name
- Microtainer Brand Tube with Edta
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- March 17, 1993
- Decision date
- September 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
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| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
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Questions and answers
When was Microtainer Brand Tube with Edta cleared by the FDA?
Microtainer Brand Tube with Edta (K931368) received a 510(k) decision of Substantially Equivalent on September 28, 1993, 195 days after the submission was received.
What is the product code of K931368?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.