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Latelet Retention Column

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K771523

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771523 Date22 Nov 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JBZ
Device Class
Class II
Regulation
21 CFR Part 864.6650
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Latelet Retention Column is a Study, Platelet Adhesive device, classified as a Class 2 Hematology device. It is used in the field of Hematology. The device has a product code of JBZ and is regulated under regulation number 864.6650. The Latelet Retention Column is substantially equivalent to other devices in its class.

The Latelet Retention Column is supplied by Bd Becton Dickinson Vacutainer Systems Preanalytic and has been cleared through the Traditional 510(k) pathway. It has an FDA 510(k) clearance with the number K771523. The device is stored and used in a clinical setting, with a medical specialty description of Hematology. The device has a registration number of 1932180 and 1313525, and an FEI number of 1000119305 and 1317628.

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