Product code GHO— Hematology

EMATOLOGY DILUENT RESERVOIR CLOSURE

Classification name: Hemocytometer
Device class: Class 1
Regulation: 21 CFR 864.6160
Advisory panel: Hematology
Total cleared: 2
First cleared: 1977-07-11
Most recent: 1987-05-20

Market context for product code GHO

FDA has cleared 2 devices under product code GHO between 1977 and 1987, filed by 2 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

19871 clearance
19771 clearance

Top applicants under product code GHO

Portable Medical Laboratories, Inc.1 clearance
Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

Recent clearances under product code GHO

K871671 — URINOSCOPY FUNNELPortable Medical Laboratories, Inc.·1987-05-20
K770980 — EMATOLOGY DILUENT RESERVOIR CLOSUREBd Becton Dickinson Vacutainer Systems Preanalytic·1977-07-11

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