Cleared Traditional

CYTO-CHEX BCT

K080552 · Streck · Hematology
Jul 2008
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K080552 is an FDA 510(k) clearance for the CYTO-CHEX BCT, a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on July 31, 2008, 154 days after receiving the submission on February 28, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K080552 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2008
Decision Date July 31, 2008
Days to Decision 154 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIM — Tubes, Vacuum Sample, With Anticoagulant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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