SCIMEDX PHASE II PR3 IGG ANTIBODY EIA— 510(k) K010287

Substantially Equivalent

Scimedx Corp.

FDA 510(k) clearance K010287 for SCIMEDX PHASE II PR3 IGG ANTIBODY EIA, Substantially Equivalent on 2001-03-16. Applicant: Scimedx Corp..

Clearance details

Applicant: Scimedx Corp.
Product code: Code MOB
Advisory panel: Immunology
Date received: 2001-01-31
Decision date: 2001-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denvill, NJ, US

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