KITClass I

Media And Components, Synthetic Cell And Tissue Culture

21 CFR 864.2220 / Hematology

KIT is the FDA product code for Media And Components, Synthetic Cell And Tissue Culture, a class I device type, regulated under 21 CFR 864.2220. As of 2026-09-10, FDA records hold 367 510(k) clearances under this code, the most recent dated 1989-05-22, and 4 recalls.

Classification record

Product code: KIT
Device name: Media And Components, Synthetic Cell And Tissue Culture
Regulation: 21 CFR 864.2220
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 367
Ingested recalls: 4

Clearances, product code KIT

By decision year

367 clearances under product code KIT with a decision year between 1977 and 1989, 1988 the highest year at 124.

Show the numbers

510(k) clearances under FDA product code KIT by decision year
Year	Clearances
1977	1
1980	1
1981	18
1982	27
1983	29
1984	21
1985	68
1986	22
1987	52
1988	124
1989	4

Applicants with the most clearances

Product code KIT

Applicants holding the most 510(k) clearances under product code KIT
Applicant	Clearances
J R Scientific	132
Sigma Chemical Co.	87
Dutchland Laboratories, Inc.	42
Hazleton Research Products, Inc.	34
Mediatech, Inc.	23
Bartels Immunodiagnostic Supplies, Inc.	5
Tissue Culture Innovations	5
Clonetics Corp.	4
Bioclinical Laboratory Services, Inc.	3
Earl-Clay Laboratories, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order