Cleared Traditional

RAPIDTEG TEG-ACT TEST

K062604 · Haemoscope Corp. · Hematology
Jan 2007
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K062604 is an FDA 510(k) clearance for the RAPIDTEG TEG-ACT TEST, a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP), submitted by Haemoscope Corp. (Niles, US). The FDA issued a Cleared decision on January 31, 2007, 152 days after receiving the submission on September 1, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number K062604 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2006
Decision Date January 31, 2007
Days to Decision 152 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JBP — Activated Whole Blood Clotting Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7140

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