Cleared Traditional

PHOSPHOPLASTIN RL

K040296 · R2 Diagnostics, Inc. · Hematology
May 2004
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K040296 is an FDA 510(k) clearance for the PHOSPHOPLASTIN RL, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on May 24, 2004, 105 days after receiving the submission on February 9, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K040296 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2004
Decision Date May 24, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750