Cleared Traditional

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-?2 Glycoprotein-I IgM

K221359 · Instrumentation Laboratory CO · Hematology
Sep 2023
Decision
506d
Days
Class 2
Risk

About This 510(k) Submission

K221359 is an FDA 510(k) clearance for the ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-?2 Glycoprotein-I IgM, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 29, 2023, 506 days after receiving the submission on May 11, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K221359 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2022
Decision Date September 29, 2023
Days to Decision 506 days
Submission Type Traditional
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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