BD Vacutainer Plasma Separator Tubes (PST), BD Vacutainer Sodium Heparin Blood Collection Tubes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252040 FDA 510(k)
- FDA Product Code
- JKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Vacutainer Plasma Separator Tubes (PST) and Sodium Heparin Blood Collection Tubes are blood collection devices designed for plasma separation and anticoagulation. These tubes feature a polymer gel separator in the PST variant, which stabilises plasma during centrifugation, while the Sodium Heparin tubes prevent clotting via heparin anticoagulation.
These devices are intended for use in clinical chemistry settings, where venous blood specimens are collected by healthcare professionals. Supplied as single-use items, they require centrifugation at ≤1300 RCF for 10 minutes to separate plasma from cellular components. Authorised under FDA 510(k) clearance (K252040), they adhere to traditional review standards and are classified under product code JKA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Vacutainer® PST™ Tubes - 367960 | BD, BD Vacutainer® blood collection tubes | BD, BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium ..., BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252040 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K252040 24 fields · synced Sep 18, 2026