ClearanceBrief
Panels › Pathology › Product code KPA · Class 1

Slide Stainer, Automated

Regulation 864.3800

0510(k)s in 12 months (21 all time)
0recalls in 12 months (30 all time)
0recalls that name a 510(k)
Get daily alerts for KPASample briefCSV

Top companies in KPA

DateFirm and productCodeLinked 510(k)
May 29, 2024Agilent Technologies
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: M
Open, Classified
KPANone listed
Jul 12, 2022Ventana Medical Systems Inc
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Open, Classified
KPANone listed
Apr 8, 2022Ventana Medical Systems Inc
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Open, Classified
KPANone listed
Apr 16, 2021Hardy Diagnostics
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Terminated
KPANone listed
Feb 25, 2021Biocare Medical, LLC
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Terminated
KPANone listed
Aug 31, 2020Roche Diagnostics Operations, Inc.
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Open, Classified
KPANone listed
Aug 31, 2020Roche Diagnostics Operations, Inc.
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Open, Classified
KPANone listed
May 21, 2020Dako Denmark A/S
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Terminated
KPANone listed
Oct 4, 2019Ventana Medical Systems Inc
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic,
Completed
KPANone listed
Sep 17, 2018Leica Microsystems, Inc.
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Terminated
KPANone listed
Jun 13, 2018Leica Microsystems, Inc.
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histologic
Terminated
KPANone listed
Mar 23, 2018BioMerieux SA
The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI Color Gram instrumen
Terminated
KPANone listed
Jul 8, 2016Hardy Diagnostics
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Terminated
KPANone listed
Apr 29, 2015Dako North America Inc.
Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient
Terminated
KPANone listed
Mar 16, 2015Dako North America Inc.
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
Terminated
KPANone listed
Sep 26, 2014Dako North America Inc.
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compa
Terminated
KPANone listed
Aug 28, 2013Ventana Medical Systems Inc
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automaticall
Terminated
KPANone listed
Aug 6, 2013Ventana Medical Systems Inc
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically st
Terminated
KPANone listed
Aug 6, 2013Ventana Medical Systems Inc
VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically st
Terminated
KPANone listed
Dec 19, 2012Dako Denmark A/S
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack c
Terminated
KPANone listed
Aug 20, 2012Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blo
Terminated
KPANone listed
Aug 31, 2010Abbott Molecular
VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: a) list 02J11-013, part number
Terminated
KPANone listed
Feb 25, 2010Beckman Coulter Inc
GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to t
Terminated
KPANone listed
Feb 25, 2010Beckman Coulter Inc
COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to t
Terminated
KPANone listed
Jan 24, 2008Ventana Medical Systems Inc
Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ
Terminated
KPANone listed
Jan 24, 2008Ventana Medical Systems Inc
Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc, Tucson, AZ
Terminated
KPANone listed
Jan 24, 2008Ventana Medical Systems Inc
Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Ventana Medical Systems Inc, Tucson, AZ
Terminated
KPANone listed
Jan 24, 2008Ventana Medical Systems Inc
Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Ventana Medical Systems Inc, Tucson, AZ
Terminated
KPANone listed
Jan 24, 2008Ventana Medical Systems Inc
Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc, Tucson, AZ
Terminated
KPANone listed
Nov 21, 2006Dako Colorado, Inc.
Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)
Terminated
KPANone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.