Cleared Special

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

K061014 · Helena Laboratories · Hematology
May 2006
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K061014 is an FDA 510(k) clearance for the ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 10, 2006, 27 days after receiving the submission on April 13, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K061014 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2006
Decision Date May 10, 2006
Days to Decision 27 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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