THROMBO TEK PSE, MODEL 90-480— 510(k) K082631

Name: FDA 510(k) clearance K082631
Creator: U.S. Food and Drug Administration
Published: 2008-12-17

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K082631 for THROMBO TEK PSE, MODEL 90-480, Substantially Equivalent on 2008-12-17. Applicant: R2 Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2008-09-10
Decision date: 2008-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

view all

K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K214002 — CRYOcheck Chromogenic Factor IX2022-12-23
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09

More clearances from R2 Diagnostics, Inc.

view all

K102851 — NOFACT VIII2011-12-19
K102908 — NOFACT IX2011-12-19
K090105 — LUPOTEK KCT2010-12-30
K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA2010-06-25
K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-22007-03-16

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