SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM— 510(k) K020689

Name: FDA 510(k) clearance K020689
Creator: U.S. Food and Drug Administration
Published: 2002-10-31

Substantially Equivalent

Midi, Inc.

FDA 510(k) clearance K020689 for SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM, Substantially Equivalent on 2002-10-31. Applicant: Midi, Inc.. Device class: 1.

Clearance details

Applicant: Midi, Inc.
Product code: Code NJO
Device class: Class 1
Regulation: 21 CFR 866.3370
Advisory panel: Microbiology
Date received: 2002-03-04
Decision date: 2002-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

More clearances from Midi, Inc.

view all

K052485 — SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF2006-01-17

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