HZTClass I

Reagent, Schiff

21 CFR 864.1850 / Hematology

HZT is the FDA product code for Reagent, Schiff, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1988-08-05, and 2 recalls.

Classification record

Product code: HZT
Device name: Reagent, Schiff
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: 5
Ingested recalls: 2

Clearances, product code HZT

By decision year

5 clearances under product code HZT with a decision year between 1976 and 1988, 1984 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HZT by decision year
Year	Clearances
1976	1
1984	3
1988	1

Applicants with the most clearances

Product code HZT

Applicants holding the most 510(k) clearances under product code HZT
Applicant	Clearances
E K Ind., Inc.	2
Harleco	1
Sigma Chemical Co.	1
Surgipath Medical Industries, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order