Cleared Traditional

AVL OMNI ANALYZER

K954018 · Avl Scientific Corp. · Hematology
Oct 1995
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K954018 is an FDA 510(k) clearance for the AVL OMNI ANALYZER, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on October 5, 1995, 41 days after receiving the submission on August 25, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K954018 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1995
Decision Date October 05, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620