Cleared Traditional

CELLTRAK-B

K834585 · R&D Systems, Inc. · Hematology
May 1984
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K834585 is an FDA 510(k) clearance for the CELLTRAK-B, a Device, Patient Transfer, Powered (Class II — Special Controls, product code FRZ), submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984, 125 days after receiving the submission on December 29, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 880.6775.

Submission Details

510(k) Number K834585 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1983
Decision Date May 02, 1984
Days to Decision 125 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code FRZ — Device, Patient Transfer, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6775