ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805— 510(k) K060431

Name: FDA 510(k) clearance K060431
Creator: U.S. Food and Drug Administration
Published: 2006-06-19

Substantially Equivalent

Mbl International Corporation

FDA 510(k) clearance K060431 for ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805, Substantially Equivalent on 2006-06-19. Applicant: Mbl International Corporation. Device class: 2.

Clearance details

Applicant: Mbl International Corporation
Product code: Code NYO
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2006-02-21
Decision date: 2006-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NYO

view all

K202541 — EliA RNA Pol III2021-09-13
K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA2018-03-30
K070066 — QUANTA LITE RNA POL III ELISA2007-04-11

More clearances from Mbl International Corporation

view all

K071961 — MESACUP MODELS BP180 AND BP230 ELISA KITS2008-08-25

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