Cleared Traditional

LIQUICHEK HEMATOLOGY CONTROL (A)

K041457 · Bio-Rad · Hematology
Jun 2004
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K041457 is an FDA 510(k) clearance for the LIQUICHEK HEMATOLOGY CONTROL (A), a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on June 28, 2004, 27 days after receiving the submission on June 1, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K041457 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2004
Decision Date June 28, 2004
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625