S-MONOVETTE EDTA K2-GEL— 510(k) K031359

Name: FDA 510(k) clearance K031359
Creator: U.S. Food and Drug Administration
Published: 2003-09-12

Substantially Equivalent

Sarstedt, Inc.

FDA 510(k) clearance K031359 for S-MONOVETTE EDTA K2-GEL, Substantially Equivalent on 2003-09-12. Applicant: Sarstedt, Inc.. Device class: 2.

Clearance details

Applicant: Sarstedt, Inc.
Product code: Code PJE
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2003-04-30
Decision date: 2003-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PJE

view all

K231469 — PAXgene® Blood DNA Tube2023-06-21
K142821 — PAXgene Blood DNA Tube2015-09-09
K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES2005-04-15
K014104 — VACUETTE EDTA K2 TUBES2002-02-01
K012043 — VACUETTE EDTA K2 GEL TUBES2001-09-24

More clearances from Sarstedt, Inc.

view all

K051019 — SAFETY NEEDLE2005-07-25
K032150 — SAFETY-MULTIFLY2003-09-12
K024237 — URINE MONOVETTE BORIC ACID2003-04-14
K003382 — SARSTEDT NEEDLE PROTECTOR2001-03-30
K913622 — HEMOPLUS1992-01-31

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.