B&D Activated Clotting Time (Act) Test Tubes Bd-C101 (Diatomaceous Earth) and Bd-K101 (Kaolin)

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K971935 ↗

FDA Product Code

JBP

Device Class

Class II

Regulation

21 CFR Part 864.7140

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• BD Surgiphor Antimicrobial Irrigation System

  Class II

  FDA 510(k) K221504 Active Cleared 14 Oct 2022

• 0.9% Sodium Chloride Injection, Usp Bd Pre-Filled Flush Syringe

  Class II

  FDA 510(k) K011982 Active Cleared 17 Jul 2001

• Modification to: Bd Durasafe Plus Epidural Lock Cse Needle Set/Kit

  Class II

  FDA 510(k) K012584 Active Cleared 6 Sep 2001

• Bd Bifurcated Needle, Models 301754, 301755, 301756, 301757

  Class II

  FDA 510(k) K020523 Active Cleared 20 Mar 2002

• Bd Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits

  Class I

  FDA 510(k) K024240 Active Cleared 26 Mar 2003

• Bd Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe

  Class II

  FDA 510(k) K011967 Active Cleared 23 Jan 2002

See all devices from Bd →