Product code HZH— Hematology

ORANGE G, 1%

Classification name: Orange G
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Total cleared: 4
First cleared: 1980-02-22
Most recent: 1984-09-07

Market context for product code HZH

FDA has cleared 4 devices under product code HZH between 1980 and 1984, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19841 clearance
19821 clearance
19811 clearance
19801 clearance

Top applicants under product code HZH

Volu Sol Medical Industries2 clearances
Surgipath1 clearance
E K Ind., Inc.1 clearance

Recent clearances under product code HZH

K842924 — ORANGE G, 1%E K Ind., Inc.·1984-09-07
K822038 — VOLU-SOL ORANGE G-6(GILLS-MODVolu Sol Medical Industries·1982-08-03
K811825 — ORANGE G-6Surgipath·1981-07-10
K800323 — VOLU-SOL ORANGE G-6 STAINVolu Sol Medical Industries·1980-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.