Product code KJR— Hematology

FETAL CHECK

Classification name: Erythrosin B
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Total cleared: 3
First cleared: 1979-12-18
Most recent: 1984-08-28

Market context for product code KJR

FDA has cleared 3 devices under product code KJR between 1979 and 1984, 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

19842 clearances
19791 clearance

Top applicants under product code KJR

Bartels Immunodiagnostic Supplies, Inc.2 clearances
Alta Diagnostics, Inc.1 clearance

Recent clearances under product code KJR

K842833 — PMK PRIMARY MONKEY KIDNEY-CELLSBartels Immunodiagnostic Supplies, Inc.·1984-08-28
K842834 — HEP-2 CELLSBartels Immunodiagnostic Supplies, Inc.·1984-08-28
K792546 — FETAL CHECKAlta Diagnostics, Inc.·1979-12-18

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