PEFAKIT APC-R FACTOR V LEIDEN— 510(k) K042762

Name: FDA 510(k) clearance K042762
Creator: U.S. Food and Drug Administration
Published: 2004-12-22

Substantially Equivalent

Pentapharm , Ltd.

FDA 510(k) clearance K042762 for PEFAKIT APC-R FACTOR V LEIDEN, Substantially Equivalent on 2004-12-22. Applicant: Pentapharm , Ltd.. Device class: 2.

Clearance details

Applicant: Pentapharm , Ltd.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2004-10-05
Decision date: 2004-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGW

view all

K260551 — HemosIL Factor V Leiden (APC Resistance V)2026-03-20
K090105 — LUPOTEK KCT2010-12-30
K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN2009-05-08
K060284 — CRYOCHECK CLOT APCR2006-05-10
K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE2004-02-04

More clearances from Pentapharm , Ltd.

view all

K042760 — PEFAKIT APC-R FACTOR V LEIDEN CONTROLS2004-12-22

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