Cleared Traditional

NRBC-CHEX FOR LH

K060083 · Streck · Hematology
Feb 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K060083 is an FDA 510(k) clearance for the NRBC-CHEX FOR LH, 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 9, 2006, 29 days after receiving the submission on January 11, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K060083 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2006
Decision Date February 09, 2006
Days to Decision 29 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