Cleared Traditional

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

K020914 · Helena Laboratories · Hematology
May 2002
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K020914 is an FDA 510(k) clearance for the ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770, 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 May 23, 2002, 63 days after receiving the submission on March 21, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number K020914 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2002
Decision Date May 23, 2002
Days to Decision 63 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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