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)
Top companies in KPA
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems Inc | 0 | 11 |
| Innovative Medical Systems, Inc. | 4 | 0 |
| Beckman Coulter Inc | 0 | 3 |
| Dako North America Inc. | 0 | 3 |
| American Bionetics, Inc. | 2 | 0 |
| Dako Denmark A/S | 0 | 2 |
| Hardy Diagnostics | 0 | 2 |
| Leica Microsystems, Inc. | 0 | 2 |
| Roche Diagnostics Operations, Inc. | 0 | 2 |
| Shaban Mfg. Co. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2024 | Agilent 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 |
KPA | None listed |
| Jul 12, 2022 | Ventana Medical Systems Inc Ventana HE 600 System, automated slide preparer, for use in laboratories. Open, Classified |
KPA | None listed |
| Apr 8, 2022 | Ventana Medical Systems Inc BenchMark ULTRA and DISCOVERY ULTRA Instruments Open, Classified |
KPA | None listed |
| Apr 16, 2021 | Hardy Diagnostics Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. Terminated |
KPA | None listed |
| Feb 25, 2021 | Biocare Medical, LLC BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 Terminated |
KPA | None listed |
| Aug 31, 2020 | Roche Diagnostics Operations, Inc. DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only)
Material Number: 05987750001 Open, Classified |
KPA | None listed |
| Aug 31, 2020 | Roche Diagnostics Operations, Inc. BenchMark ULTRA Advanced Staining System (IVD)-
Material Number: 05342716001 Open, Classified |
KPA | None listed |
| May 21, 2020 | Dako 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 |
KPA | None listed |
| Oct 4, 2019 | Ventana 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 |
KPA | None listed |
| Sep 17, 2018 | Leica Microsystems, Inc. BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments Terminated |
KPA | None listed |
| Jun 13, 2018 | Leica 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 |
KPA | None listed |
| Mar 23, 2018 | BioMerieux 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 |
KPA | None listed |
| Jul 8, 2016 | Hardy 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 |
KPA | None listed |
| Apr 29, 2015 | Dako 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 |
KPA | None listed |
| Mar 16, 2015 | Dako 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 |
KPA | None listed |
| Sep 26, 2014 | Dako 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 |
KPA | None listed |
| Aug 28, 2013 | Ventana 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 |
KPA | None listed |
| Aug 6, 2013 | Ventana 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 |
KPA | None listed |
| Aug 6, 2013 | Ventana 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 |
KPA | None listed |
| Dec 19, 2012 | Dako 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 |
KPA | None listed |
| Aug 20, 2012 | Beckman 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 |
KPA | None listed |
| Aug 31, 2010 | Abbott 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 |
KPA | None listed |
| Feb 25, 2010 | Beckman 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 |
KPA | None listed |
| Feb 25, 2010 | Beckman 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 |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Jan 24, 2008 | Ventana Medical Systems Inc Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc, Tucson, AZ Terminated |
KPA | None listed |
| Nov 21, 2006 | Dako Colorado, Inc. Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc.
(Catalog No. (ER 00130,00331,00230,00431) Terminated |
KPA | None listed |
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