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Vacuette With PPack

by Greiner Vacuette North America, Inc.

510(k) K002777

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002777 Date5 Oct 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Vacuette With PPack is a blood collection tube designed for venipuncture and serum separation, classified under the nomenclature for blood collection and processing devices. It features a vacuum system to draw blood into the tube and a PPack additive for clot acceleration and serum separation, ensuring reliable sample processing for clinical chemistry applications.

This device is intended for single-use in clinical laboratory settings and is supplied sterile. It is distributed as part of the VACUETTE Blood Collection Tubes system, with a product code of JKA. The device is regulated under FDA 510(k) clearance (K002777) and is intended for use in blood collection procedures where serum separation is required, adhering to standard laboratory protocols.

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