Slide Stainer, Automated
This device is an automated slide stainer used in pathology laboratories to apply histological and cytological stains to tissue or cell specimens on microscope slides, enabling visualization under a microscope. It is classified as FDA Class 1, indicating low risk and requiring only general controls. The product code is KPA, regulated under 21 CFR 864.3800 within the Pathology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KPA
- Device Class
- FDA class 1
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933996 | PROFIBLOT | Jan 28, 1994 | Substantially Equivalent | Tecan U.S., Ltd. |
| K884258 | VERSABLOT | Dec 14, 1988 | Substantially Equivalent | American Bionetics, Inc. |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | May 13, 1988 | Substantially Equivalent | Wescor, Inc. |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K874887 | WESBLOT PROCESSOR | Mar 24, 1988 | Substantially Equivalent | American Bionetics, Inc. |
| K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | Jan 05, 1988 | Substantially Equivalent | Sakura Finetek U.S.A., Inc. |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Sep 14, 1987 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K853210 | MST-1050-II X-RAY UNIT | Oct 10, 1985 | Substantially Equivalent | Radiological Engineering, Inc. |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Feb 27, 1985 | Substantially Equivalent | Shaban Mfg. Co. |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Feb 27, 1985 | Substantially Equivalent | Shaban Mfg. Co. |
| K842077 | MIDAS II AUTOMATIC STAINER | Jul 27, 1984 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER | Oct 31, 1983 | Substantially Equivalent | Wescor, Inc. |
| K832994 | MIDAS 6000 AUTOMATIC STAINER | Sep 29, 1983 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K821830 | MI DAS 1000 AUTOMATIC SLIDE STAINER | Jul 22, 1982 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K811697 | GUAMSTAINER | Jul 02, 1981 | Substantially Equivalent | Tomtec |
| K781598 | TECHNICON AUTOSLIDE STAINING/PROCESSING | Oct 17, 1978 | Substantially Equivalent | Technicon Instruments Corp. |
| K780637 | HEMATOLOGY SLIDE STAINER | May 19, 1978 | Substantially Equivalent | A. J. P. Scientific, Inc. |
| K780017 | AUTO. SLIDE STAINER | Jan 30, 1978 | Substantially Equivalent | Honeywell, Inc. |
| K771699 | CARA-STAIN MODEL 3000 | Sep 13, 1977 | Substantially Equivalent | American Safety Equipment Corp. |
| K771559 | HEMA-TEK II SLIDE STAINER | Aug 25, 1977 | Substantially Equivalent | Miles Laboratories, Inc. |
| K770076 | BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK | Mar 22, 1977 | Substantially Equivalent | Jack W. Kindberg |
FEI Numbers
This FDA classification entry is associated with 82 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 82 registration numbers. Click on an entry to view related FDA registrations.