PHOSPHOPLASTIN RL— 510(k) K040296

Name: FDA 510(k) clearance K040296
Creator: U.S. Food and Drug Administration
Published: 2004-05-24

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K040296 for PHOSPHOPLASTIN RL, Substantially Equivalent on 2004-05-24. Applicant: R2 Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2004-02-09
Decision date: 2004-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJS

view all

K253188 — CoaguChek XS Plus System2025-10-24
K251564 — microINR System2025-07-21
K243543 — microINR System2025-02-27
K230802 — Xprecia Prime Coagulation System2024-03-15
K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System2023-07-14

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
K082631 — THROMBO TEK PSE, MODEL 90-4802008-12-17

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.