KQCClass I

Stains, Hematology

21 CFR 864.1850 / Hematology

KQC is the FDA product code for Stains, Hematology, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 1988-07-28, and 5 recalls.

Classification record

Product code: KQC
Device name: Stains, Hematology
Regulation: 21 CFR 864.1850
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 5

Clearances, product code KQC

By decision year

9 clearances under product code KQC with a decision year between 1976 and 1988, 1976 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code KQC by decision year
Year	Clearances
1976	2
1979	2
1980	1
1984	2
1985	1
1988	1

Applicants with the most clearances

Product code KQC

Applicants holding the most 510(k) clearances under product code KQC
Applicant	Clearances
Geometric Data, Div. Smithkline Corp.	2
R & D Systems, Inc.	2
Anatech, Ltd.	1
Bioscientific	1
Electrophoresis Corp. of America	1
Volu Sol Medical Industries	1
Warner-Lambert Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order