KPA · Slide Stainer, Automated
Pathology · 21 CFR 864.3800 · Class 1
Overview
| Product Code | KPA |
|---|---|
| Device Name | Slide Stainer, Automated |
| Regulation | 21 CFR 864.3800 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933996 | PROFIBLOT | Tecan U.S., Ltd. | Jan 28, 1994 | SESE |
| K884258 | VERSABLOT | American Bionetics, Inc. | Dec 14, 1988 | SESE |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | Wescor, Inc. | May 13, 1988 | SESE |
| K880745 | LX-100 SLIDE STAINER | Innovative Medical Systems, Inc. | Apr 27, 1988 | SESE |
| K874887 | WESBLOT PROCESSOR | American Bionetics, Inc. | Mar 24, 1988 | SESE |
| K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | Sakura Finetek U.S.A., Inc. | Jan 5, 1988 | SESE |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Fisher Scientific Co., LLC | Sep 14, 1987 | SESE |
| K853210 | MST-1050-II X-RAY UNIT | Radiological Engineering, Inc. | Oct 10, 1985 | SESE |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Shaban Mfg. Co. | Feb 27, 1985 | SESE |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Shaban Mfg. Co. | Feb 27, 1985 | SESE |
| K842077 | MIDAS II AUTOMATIC STAINER | Innovative Medical Systems, Inc. | Jul 27, 1984 | SESE |
| K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER | Wescor, Inc. | Oct 31, 1983 | SESE |
| K832994 | MIDAS 6000 AUTOMATIC STAINER | Innovative Medical Systems, Inc. | Sep 29, 1983 | SESE |
| K821830 | MI DAS 1000 AUTOMATIC SLIDE STAINER | Innovative Medical Systems, Inc. | Jul 22, 1982 | SESE |
| K811697 | GUAMSTAINER | Tomtec | Jul 2, 1981 | SESE |
| K781598 | TECHNICON AUTOSLIDE STAINING/PROCESSING | Technicon Instruments Corp. | Oct 17, 1978 | SESE |
| K780637 | HEMATOLOGY SLIDE STAINER | A. J. P. Scientific, Inc. | May 19, 1978 | SESE |
| K780017 | AUTO. SLIDE STAINER | Honeywell, Inc. | Jan 30, 1978 | SESE |
| K771699 | CARA-STAIN MODEL 3000 | American Safety Equipment Corp. | Sep 13, 1977 | SESE |
| K771559 | HEMA-TEK II SLIDE STAINER | Miles Laboratories, Inc. | Aug 25, 1977 | SESE |
Top Applicants
- Innovative Medical Systems, Inc. — 4 clearances
- American Bionetics, Inc. — 2 clearances
- Shaban Mfg. Co. — 2 clearances
- Wescor, Inc. — 2 clearances
- A. J. P. Scientific, Inc. — 1 clearance
