Cleared Traditional

LIQUICHEK RETICULOCYTE CONTROL (A)

K042836 · Bio-Rad · Hematology
Nov 2004
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K042836 is an FDA 510(k) clearance for the LIQUICHEK RETICULOCYTE 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 November 5, 2004, 22 days after receiving the submission on October 14, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K042836 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2004
Decision Date November 05, 2004
Days to Decision 22 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