KSAClass II

Calibrator For Red-Cell And White-Cell Counting

21 CFR 864.8185 / Hematology

KSA is the FDA product code for Calibrator For Red-Cell And White-Cell Counting, a class II device type, regulated under 21 CFR 864.8185. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 1994-12-15, and no recalls.

Classification record

Product code: KSA
Device name: Calibrator For Red-Cell And White-Cell Counting
Regulation: 21 CFR 864.8185
Device class: Class II
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: 8
Ingested recalls: 0

Clearances, product code KSA

By decision year

8 clearances under product code KSA with a decision year between 1982 and 1994, 1982 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code KSA by decision year
Year	Clearances
1982	2
1985	1
1986	1
1987	1
1988	1
1990	1
1994	1

Applicants with the most clearances

Product code KSA

Applicants holding the most 510(k) clearances under product code KSA
Applicant	Clearances
R & D Systems, Inc.	3
American Dade	1
Coulter Electronics, Inc.	1
Hematology Marketing Assoc.	1
Streck Laboratories, Inc.	1
Technicon Instruments Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order