Cleared Traditional

NRBC-CHEX FOR ADVIA

K080016 · Streck · Hematology
Feb 2008
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K080016 is an FDA 510(k) clearance for the NRBC-CHEX FOR ADVIA, a Control, Red-cell (Class II — Special Controls, product code GJR), submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 5, 2008, 33 days after receiving the submission on January 3, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K080016 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2008
Decision Date February 05, 2008
Days to Decision 33 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJR — Control, Red-cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625