Cleared Traditional

SICKLE-CHEX SOLUBILITY KIT

K023656 · Streck Laboratories, Inc. · Hematology
Dec 2002
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K023656 is an FDA 510(k) clearance for the SICKLE-CHEX SOLUBILITY KIT, 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 December 30, 2002, 61 days after receiving the submission on October 30, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K023656 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2002
Decision Date December 30, 2002
Days to Decision 61 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