Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart D — Pathology Instrumentation and Accessories](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories) → [21 CFR 864.3800](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3800) → KPA — Slide Stainer, Automated # KPA · Slide Stainer, Automated _Pathology · 21 CFR 864.3800 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA ## Overview - **Product Code:** KPA - **Device Name:** Slide Stainer, Automated - **Regulation:** [21 CFR 864.3800](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3800) - **Device Class:** 1 - **Review Panel:** [Pathology](/submissions/PA) ## 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](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K933996.md) | PROFIBLOT | Tecan U.S., Ltd. | Jan 28, 1994 | SESE | | [K884258](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K884258.md) | VERSABLOT | American Bionetics, Inc. | Dec 14, 1988 | SESE | | [K881592](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K881592.md) | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | Wescor, Inc. | May 13, 1988 | SESE | | [K880745](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K880745.md) | LX-100 SLIDE STAINER | Innovative Medical Systems, Inc. | Apr 27, 1988 | SESE | | [K874887](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K874887.md) | WESBLOT PROCESSOR | American Bionetics, Inc. | Mar 24, 1988 | SESE | | [K874897](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K874897.md) | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | Sakura Finetek U.S.A., Inc. | Jan 5, 1988 | SESE | | [K872916](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K872916.md) | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Fisher Scientific Co., LLC | Sep 14, 1987 | SESE | | [K853210](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K853210.md) | MST-1050-II X-RAY UNIT | Radiological Engineering, Inc. | Oct 10, 1985 | SESE | | [K850333](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K850333.md) | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Shaban Mfg. Co. | Feb 27, 1985 | SESE | | [K850157](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K850157.md) | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Shaban Mfg. Co. | Feb 27, 1985 | SESE | | [K842077](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K842077.md) | MIDAS II AUTOMATIC STAINER | Innovative Medical Systems, Inc. | Jul 27, 1984 | SESE | | [K833295](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K833295.md) | WESCOR 7100 AEROSPRAY SLIDE STAINER | Wescor, Inc. | Oct 31, 1983 | SESE | | [K832994](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K832994.md) | MIDAS 6000 AUTOMATIC STAINER | Innovative Medical Systems, Inc. | Sep 29, 1983 | SESE | | [K821830](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K821830.md) | MI DAS 1000 AUTOMATIC SLIDE STAINER | Innovative Medical Systems, Inc. | Jul 22, 1982 | SESE | | [K811697](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K811697.md) | GUAMSTAINER | Tomtec | Jul 2, 1981 | SESE | | [K781598](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K781598.md) | TECHNICON AUTOSLIDE STAINING/PROCESSING | Technicon Instruments Corp. | Oct 17, 1978 | SESE | | [K780637](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K780637.md) | HEMATOLOGY SLIDE STAINER | A. J. P. Scientific, Inc. | May 19, 1978 | SESE | | [K780017](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K780017.md) | AUTO. SLIDE STAINER | Honeywell, Inc. | Jan 30, 1978 | SESE | | [K771699](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K771699.md) | CARA-STAIN MODEL 3000 | American Safety Equipment Corp. | Sep 13, 1977 | SESE | | [K771559](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA/K771559.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/KPA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com