Cleared Traditional

XE CHECK

K994388 · Streck Laboratories, Inc. · Hematology
Jan 2000
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K994388 is an FDA 510(k) clearance for the XE CHECK, a Mixture, Control, White-cell And Red-cell Indices (Class II — Special Controls, product code GLQ), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on January 14, 2000, 17 days after receiving the submission on December 28, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K994388 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1999
Decision Date January 14, 2000
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GLQ — Mixture, Control, White-cell And Red-cell Indices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625