Ocean Scientific Vacutest

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K863976 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Immuno-Wash Automated Tube Washer

  Class I

  FDA 510(k) K893810 Active Cleared 3 Aug 1989

• Mini-Chem Analyzer

  Class I

  FDA 510(k) K860987 Active Cleared 5 May 1986

• Micro-Chem Analyzer

  Class I

  FDA 510(k) K873638 Active Cleared 29 Sep 1987

• Chem-Stat Analyzer

  Class I

  FDA 510(k) K840340 Active Cleared 23 Mar 1984

• Ocean Scientific Vdrl Test

  Class II

  FDA 510(k) K864731 Active Cleared 10 Mar 1987

• What is the Ocean Scientific Vacutest used for?

  The Ocean Scientific Vacutest is designed specifically for collecting venous blood samples in clinical settings. It ensures accurate and reliable specimen collection for laboratory analysis, including chemistry, hematology, and serology tests. The sealed, evacuated system minimizes contamination risks and preserves sample integrity for precise diagnostic testing.

• Is the Vacutest single-use or reusable?

  The Vacutest is intended for single-use only. This design choice prevents cross-contamination between patients and ensures sterility for each collection, adhering to clinical best practices for blood handling and reducing infection risks.

• How should Vacutest tubes be stored to maintain sterility?

  Vacutest tubes must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage protects the sterile barrier and prevents degradation of the evacuated system, ensuring the tube remains functional and safe for use when needed.

• What sizes or configurations are available for the Vacutest?

  The Vacutest is available in standard sizes and configurations as outlined in the product documentation. While exact dimensions or volume capacities are not specified here, these tubes are designed to meet common clinical laboratory requirements for venous blood collection.

• What regulatory clearance does the Vacutest hold?

  The Vacutest holds FDA 510(k) clearance under the product code JKA, classified under Clinical Chemistry. This clearance confirms it is substantially equivalent to a legally marketed device and meets U.S. regulatory standards for blood collection tubes.