Cleared Traditional

RETIC-CHEX FOR CELL-DYN

K042587 · Streck Laboratories, Inc. · Hematology
Oct 2004
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K042587 is an FDA 510(k) clearance for the RETIC-CHEX FOR CELL-DYN, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on October 19, 2004, 27 days after receiving the submission on September 22, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K042587 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2004
Decision Date October 19, 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