MDI DS-DNA TEST— 510(k) K000477

Substantially Equivalent

Micro Detect, Inc.

FDA 510(k) clearance K000477 for MDI DS-DNA TEST, Substantially Equivalent on 2000-03-01. Applicant: Micro Detect, Inc.. Device class: 2.

Clearance details

Applicant: Micro Detect, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2000-02-14
Decision date: 2000-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRM

K101319 — IMMULISA DSDNA ANTIBODY ELISA2010-12-09
K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)2009-04-15
K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT2006-11-21
K040811 — VARELISA SSDNA ANTIBODIES, MODEL 148962004-05-13
K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST2000-09-11

More clearances from Micro Detect, Inc.

K003794 — ELISA TEST, SEROLOGY2001-03-30
K002358 — MDI GLIADIN A TEST2000-10-19
K002359 — MDI GLIADIN G TEST2000-10-19
K000934 — MDI SCL-70 TEST2000-04-07
K993843 — MDI RF TEST2000-01-11

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