Cleared Traditional

K964406 - AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (FDA 510(k) Clearance)

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

K964406 is an FDA 510(k) clearance for the AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER. This device is classified as 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 FDA review panel. Regulated under 21 CFR 864.5950.

Submission Details

510(k) Number K964406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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