Cleared Traditional

ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752

K013078 · Helena Laboratories · Hematology
Jan 2002
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K013078 is an FDA 510(k) clearance for the ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752, a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 10, 2002, 118 days after receiving the submission on September 14, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number K013078 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2001
Decision Date January 10, 2002
Days to Decision 118 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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