Product code DCE— Immunology

ANTISERA, RHODAMINE CONJUGATED FRAGMENT

Classification name: Fab, Antigen, Antiserum, Control
Device class: Class 1
Regulation: 21 CFR 866.5520
Advisory panel: Immunology
Total cleared: 2
First cleared: 1977-11-22
Most recent: 1979-02-16

Market context for product code DCE

FDA has cleared 2 devices under product code DCE between 1977 and 1979, filed by 1 applicant company. 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

19791 clearance
19771 clearance

Top applicants under product code DCE

Kallestad Laboratories, Inc.2 clearances

Recent clearances under product code DCE

K781951 — ANTISERA, RHODAMINE CONJUGATED FRAGMENTKallestad Laboratories, Inc.·1979-02-16
K772128 — FLUORESCEIN CONJUGATEDKallestad Laboratories, Inc.·1977-11-22

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