Product code MCE— Microbiology

KALLESTAD RSV MICROPLATE EIA

Classification name: Respiratory Syncytial Virus - Elisa
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Total cleared: 2
First cleared: 1993-02-12
Most recent: 2006-09-08

Market context for product code MCE

FDA has cleared 2 devices under product code MCE between 1993 and 2006, 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

20061 clearance
19931 clearance

Top applicants under product code MCE

Quidel Corp.1 clearance
Bio-Rad Laboratories, Inc.1 clearance

Recent clearances under product code MCE

K061008 — QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199Quidel Corp.·2006-09-08
K924289 — KALLESTAD RSV MICROPLATE EIABio-Rad Laboratories, Inc.·1993-02-12

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