Cleared Traditional

SICKLE-CHEX

K013316 · Streck Laboratories, Inc. · Hematology
Nov 2001
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K013316 is an FDA 510(k) clearance for the SICKLE-CHEX, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on November 6, 2001, 33 days after receiving the submission on October 4, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K013316 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2001
Decision Date November 06, 2001
Days to Decision 33 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GHM — Test, Sickle Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7825