KPAClass I

Slide Stainer, Automated

21 CFR 864.3800 / Pathology

KPA is the FDA product code for Slide Stainer, Automated, a class I device type, regulated under 21 CFR 864.3800. As of 2026-09-10, FDA records hold 21 510(k) clearances under this code, the most recent dated 1994-01-28, and 30 recalls.

Classification record

Product code: KPA
Device name: Slide Stainer, Automated
Regulation: 21 CFR 864.3800
Device class: Class I
Review panel: Pathology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 21
Ingested recalls: 30

Clearances, product code KPA

By decision year

21 clearances under product code KPA with a decision year between 1977 and 1994, 1988 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code KPA by decision year
Year	Clearances
1977	3
1978	3
1981	1
1982	1
1983	2
1984	1
1985	3
1987	1
1988	5
1994	1

Applicants with the most clearances

Product code KPA

Applicants holding the most 510(k) clearances under product code KPA
Applicant	Clearances
Innovative Medical Systems, Inc.	4
American Bionetics, Inc.	2
Shaban Mfg. Co.	2
ELITechGroup Inc	2
A. J. P. Scientific, Inc.	1
American Safety Equipment Corp.	1
Fisher Scientific Company L.L.C.	1
Honeywell, Inc.	1
Jack W. Kindberg	1
Miles Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 78 companies shown, in name order