TPO IGG ANTIBODY EIA TEST— 510(k) K011082

Substantially Equivalent

Scimedx Corp.

FDA 510(k) clearance K011082 for TPO IGG ANTIBODY EIA TEST, Substantially Equivalent on 2001-06-06. Applicant: Scimedx Corp.. Device class: 2.

Clearance details

Applicant: Scimedx Corp.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2001-04-10
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denvill, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Scimedx Corp.

K011348 — PHASE II GBM IGG ANTIBODY EIA TEST2001-06-25
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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.