Cleared Traditional

LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH

K942209 · Bio-Rad · Hematology
Jun 1994
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K942209 is an FDA 510(k) clearance for the LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH, a Control, Cell Counter, Normal And Abnormal (Class II — Special Controls, product code JCN), submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on June 16, 1994, 42 days after receiving the submission on May 5, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K942209 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1994
Decision Date June 16, 1994
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JCN — Control, Cell Counter, Normal And Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625