Cleared Traditional

GENERAL PURPOSE CENTRIFUGE

K864974 · Norfolk Scientific, Inc. · Chemistry
Jan 1987
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K864974 is an FDA 510(k) clearance for the GENERAL PURPOSE CENTRIFUGE, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Norfolk Scientific, Inc. (Norwood, US). The FDA issued a Cleared decision on January 9, 1987, 21 days after receiving the submission on December 19, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K864974 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1986
Decision Date January 09, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

Similar Devices — JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 37
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
K183205 · Emcyte Corporation · May 2019
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
K103340 · Harvest Technologies, Corp. · Dec 2010
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
K081345 · Thermogenesis Corp. · Jul 2008
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K071934 · Biomet Manufacturing Corp · Oct 2007
GENESISCS COMPONENT CONCENTRATING SYSTEM
K070666 · Perfusion Partners & Assoc., Inc. · Jun 2007
SMARTPREP2 CENTRIFUGE SYSTEM
K052925 · Harvest Technologies, Corp. · Jan 2006