VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES— 510(k) K042927

Name: FDA 510(k) clearance K042927
Creator: U.S. Food and Drug Administration
Published: 2005-04-15

Substantially Equivalent

Greiner Bio-One Vacuette North America

FDA 510(k) clearance K042927 for VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES, Substantially Equivalent on 2005-04-15. Applicant: Greiner Bio-One Vacuette North America. Device class: 2.

Clearance details

Applicant: Greiner Bio-One Vacuette North America
Product code: Code PJE
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2004-10-22
Decision date: 2005-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PJE

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K231469 — PAXgene® Blood DNA Tube2023-06-21
K142821 — PAXgene Blood DNA Tube2015-09-09
K031359 — S-MONOVETTE EDTA K2-GEL2003-09-12
K014104 — VACUETTE EDTA K2 TUBES2002-02-01
K012043 — VACUETTE EDTA K2 GEL TUBES2001-09-24

More clearances from Greiner Bio-One Vacuette North America

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K080235 — SAFETY INFUSION SET2008-04-24
K033478 — VACUETTE QUICKSHIELD SAFETY TUBE HOLDER2003-12-29
K023971 — VACUETTE TRACE ELEMENTS TUBES2003-01-27
K011699 — VACUETTE EVACUATED BLOOD COLLECTION TUBES2001-06-28

Adverse events under product code PJE

product code PJE

Malfunction: 540
Total: 540

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.