Cleared Traditional

CYTO-CHEX BCT

K040107 · Streck Laboratories, Inc. · Hematology
Jul 2004
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K040107 is an FDA 510(k) clearance for the CYTO-CHEX BCT, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on July 27, 2004, 189 days after receiving the submission on January 20, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K040107 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2004
Decision Date July 27, 2004
Days to Decision 189 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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