PHASE II GBM IGG ANTIBODY EIA TEST— 510(k) K011348

Name: FDA 510(k) clearance K011348
Creator: U.S. Food and Drug Administration
Published: 2001-06-25

Substantially Equivalent

Scimedx Corp.

FDA 510(k) clearance K011348 for PHASE II GBM IGG ANTIBODY EIA TEST, Substantially Equivalent on 2001-06-25. Applicant: Scimedx Corp.. Device class: 2.

Clearance details

Applicant: Scimedx Corp.
Product code: Code MVJ
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2001-05-02
Decision date: 2001-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denvill, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MVJ

view all

K071219 — ATHENA MULTI-LYTE GBM TEST SYSTEM2007-12-06
K072358 — BIOPLEX VASCULITIS KIT2007-10-31
K991890 — AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA1999-08-09
K984619 — BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT1999-02-23
K984336 — QUANTA LITE GBM ELISA1999-02-08

More clearances from Scimedx Corp.

view all

K011082 — TPO IGG ANTIBODY EIA TEST2001-06-06
K010625 — EUROSPITAL EU-TTG IGA UMANA2001-04-24
K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA2001-03-16
K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA2001-03-07
K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM2000-10-19

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