VACUETTE EDTA K2 TUBES— 510(k) K014104

Name: FDA 510(k) clearance K014104
Creator: U.S. Food and Drug Administration
Published: 2002-02-01

Substantially Equivalent

Greiner Vacuette North America, Inc.

FDA 510(k) clearance K014104 for VACUETTE EDTA K2 TUBES, Substantially Equivalent on 2002-02-01. Applicant: Greiner Vacuette North America, Inc.. Device class: 2.

Clearance details

Applicant: Greiner Vacuette North America, Inc.
Product code: Code PJE
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2001-12-13
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

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K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES2005-04-15
K031359 — S-MONOVETTE EDTA K2-GEL2003-09-12
K012043 — VACUETTE EDTA K2 GEL TUBES2001-09-24

More clearances from Greiner Vacuette North America, Inc.

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K011786 — VACUETTE SAFETY BLOOD COLLECTION SET2001-07-12
K003812 — VACUETTE SPEEDY QUICK-RELEASE HOLDER2001-04-30
K002777 — VACUETTE WITH PPACK2000-10-05

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.