Cleared Traditional

STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01

K881254 · Norfolk Scientific, Inc. · Chemistry
Apr 1988
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K881254 is an FDA 510(k) clearance for the STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01, 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 April 5, 1988, 13 days after receiving the submission on March 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K881254 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1988
Decision Date April 05, 1988
Days to Decision 13 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