Cleared Traditional

AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER

K964406 · Daxor Corporation · Hematology
Sep 1997
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K964406 is an FDA 510(k) clearance for the AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER, a Device, Blood Volume Measuring (Class II — Special Controls, product code JWO), submitted by Daxor Corporation (New York, US). The FDA issued a Cleared decision on September 25, 1997, 325 days after receiving the submission on November 4, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5950.

Submission Details

510(k) Number K964406 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1996
Decision Date September 25, 1997
Days to Decision 325 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JWO — Device, Blood Volume Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5950