Napsac(Tm)

FDA 510(k) K871830 · Beecher Medical Diagnostic Instrumentation

Substantially Equivalent

510(k) numberK871830

Submission

Device name
Napsac(Tm)
Applicant
Beecher Medical Diagnostic Instrumentation
Silver Spring, MD, US
Received
May 11, 1987
Decision date
September 9, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKL – Counter, Cell, Automated (Particle Counter)
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5200
Specialty
Hematology

Other 510(k)s with product code GKL

510(k)DeviceApplicantDecision
K152776Glocyte Automated Cell Counter SystemGKL · Traditional Advanced Instruments, Inc.05/27/2016SE
K091539Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional Iris Diagnostics08/31/2010SE
K071652Hemocue WBC SystemGKL · Traditional Hemocue AB10/25/2007SE
K051693Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional Bayer Healthcare, LLC12/07/2005SE
K050235Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional Iris International, Inc.03/23/2005SE
K032677Sysmex POCH-100IGKL · Traditional Sysmex America, Inc.02/11/2004SE
K022331Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special Bayer Diagnostics Corp.09/11/2002SE
K001683Sysmex R-500GKL · Traditional Sysmex Corporation of America08/21/2000SE
K991070Coulter Z2 AnalyzerGKL · Traditional Coulter Corp.05/11/1999SE
K981950Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional Sysmex Corp.11/03/1998SE

More from Sysmex Corp.

510(k)DeviceDecision
K850288Hepatic Parenchymal Suction DissectorGDI · Traditional 03/18/1985SE
K833800Beecher 20 Ga. ProbeHQC · Traditional 01/04/1984SE

Questions and answers

When was Napsac(Tm) cleared by the FDA?

Napsac(Tm) (K871830) received a 510(k) decision of Substantially Equivalent on September 9, 1987, 121 days after the submission was received.

What is the product code of K871830?

The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.