Cleared Traditional

NAPSAC(TM)

K871830 · Beecher Medical Diagnostic Instrumentation · Hematology
Sep 1987
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K871830 is an FDA 510(k) clearance for the NAPSAC(TM), a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Beecher Medical Diagnostic Instrumentation (Silver Spring, US). The FDA issued a Cleared decision on September 9, 1987, 121 days after receiving the submission on May 11, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K871830 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1987
Decision Date September 09, 1987
Days to Decision 121 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

Similar Devices — GKL Counter, Cell, Automated (particle Counter)

All 129
Glocyte Automated Cell Counter System
K152776 · Advanced Instruments, Inc. · May 2016
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
K091539 · Iris Diagnostics · Aug 2010
HEMOCUE WBC SYSTEM
K071652 · Hemocue AB · Oct 2007
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · Bayer Healthcare, LLC · Dec 2005
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
K050235 · Iris International, Inc. · Mar 2005
SYSMEX POCH-100I
K032677 · Sysmex America, Inc. · Feb 2004