Product code KPA
- Device name
- Slide Stainer, Automated
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3800
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933996 | PROFIBLOT | Tecan U.S., Ltd. | 1994-01-28 |
| K884258 | VERSABLOT | American Bionetics, Inc. | 1988-12-14 |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | Wescor, Inc. | 1988-05-13 |
| K880745 | LX-100 SLIDE STAINER | Innovative Medical Systems, Inc. | 1988-04-27 |
| K874887 | WESBLOT PROCESSOR | American Bionetics, Inc. | 1988-03-24 |
| K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | Sakura Finetek U.S.A., Inc. | 1988-01-05 |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Fisher Scientific Co., LLC | 1987-09-14 |
| K853210 | MST-1050-II X-RAY UNIT | Radiological Engineering, Inc. | 1985-10-10 |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Shaban Mfg. Co. | 1985-02-27 |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Shaban Mfg. Co. | 1985-02-27 |
| K842077 | MIDAS II AUTOMATIC STAINER | Innovative Medical Systems, Inc. | 1984-07-27 |
| K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-31 |
| K832994 | MIDAS 6000 AUTOMATIC STAINER | Innovative Medical Systems, Inc. | 1983-09-29 |
| K821830 | MI DAS 1000 AUTOMATIC SLIDE STAINER | Innovative Medical Systems, Inc. | 1982-07-22 |
| K811697 | GUAMSTAINER | Tomtec | 1981-07-02 |
| K781598 | TECHNICON AUTOSLIDE STAINING/PROCESSING | Technicon Instruments Corp. | 1978-10-17 |
| K780637 | HEMATOLOGY SLIDE STAINER | A. J. P. Scientific, Inc. | 1978-05-19 |
| K780017 | AUTO. SLIDE STAINER | Honeywell, Inc. | 1978-01-30 |
| K771699 | CARA-STAIN MODEL 3000 | American Safety Equipment Corp. | 1977-09-13 |
| K771559 | HEMA-TEK II SLIDE STAINER | Miles Laboratories, Inc. | 1977-08-25 |
| K770076 | BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK | Jack W. Kindberg | 1977-03-22 |
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|---|---|---|---|
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| 00380740213572 | Alinity | ABBOTT LABORATORIES | 2025-12-25 |
| 07613336140956 | BenchMark GX | Ventana Medical Systems, Inc. | 2025-12-15 |
| 04015630984510 | BenchMark Special Stains Stainer Module | Ventana Medical Systems, Inc. | 2025-12-15 |
| 05700571112182 | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2025-09-02 |
| 05700575000416 | Dako Omnis 165 Duo | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2025-07-01 |
| 09349458005689 | BOND-MAX Processing Module | LEICA BIOSYSTEMS MELBOURNE PTY LTD | 2025-06-30 |
| 09349458005672 | BOND-III Processing Module | LEICA BIOSYSTEMS MELBOURNE PTY LTD | 2025-06-30 |
| 05700575000430 | Dako Omnis 165 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2025-06-24 |
| 05700572034568 | Dako | AGILENT TECHNOLOGIES, INC. | 2024-08-07 |
| 05700572034551 | Dako | AGILENT TECHNOLOGIES, INC. | 2024-08-07 |
| 05700571107713 | Dako | AGILENT TECHNOLOGIES, INC. | 2024-08-07 |
| 10860008222432 | ASP VIAL | ASP Health Inc. | 2024-04-05 |
| 10860008222418 | ASP POD | ASP Health Inc. | 2024-04-05 |
| B92112631 | HistoPro® | RUSHABH INSTRUMENTS, LLC | 2022-12-17 |
| B92112691 | HistoPro® | RUSHABH INSTRUMENTS, LLC | 2022-12-17 |
| B92113917 | HistoPro® | RUSHABH INSTRUMENTS, LLC | 2022-12-17 |
| B92115391 | HistoPro® | RUSHABH INSTRUMENTS, LLC | 2022-12-17 |
| 05700571104859 | User-Fillable Reagent Bottle 12mL Capacity (Link) | AGILENT TECHNOLOGIES, INC. | 2020-09-17 |
| 05700571104873 | User-Fillable Reagent Bottle 50mL Capacity (Link) | AGILENT TECHNOLOGIES, INC. | 2020-09-17 |
| 05700571104866 | User-Fillable Reagent Bottle 25mL Capacity (Link) | AGILENT TECHNOLOGIES, INC. | 2020-09-17 |
| 05700571104842 | User-Fillable Reagent Bottle 5mL Capacity (Link) | AGILENT TECHNOLOGIES, INC. | 2020-09-17 |
| 03573026227760 | PREVI® COLOR SINGLE SAMPLE CHAMBERS FAST (WHITE) | BIOMERIEUX SA | 2020-08-14 |
| 03573026227753 | PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE | BIOMERIEUX SA | 2020-08-14 |
| 03573026227746 | PREVI® COLOR POLY-L-LYSINE SLIDES DUAL | BIOMERIEUX SA | 2020-08-14 |
| 03573026227739 | PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN) | BIOMERIEUX SA | 2020-08-14 |
| 03573026227722 | PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE) | BIOMERIEUX SA | 2020-08-14 |
| 03573026227777 | PREVI® COLOR SINGLE SAMPLE CHAMBERS SLOW (TAN) | BIOMERIEUX SA | 2020-08-14 |
| 04015630981052 | BenchMark ULTRA | Ventana Medical Systems, Inc. | 2014-09-19 |
| 04015630981069 | BenchMark XT | Ventana Medical Systems, Inc. | 2014-09-19 |