ACE(TM) CEDIA(R) FERRITIN ASSAY— 510(k) K950393

Name: FDA 510(k) clearance K950393
Creator: U.S. Food and Drug Administration
Published: 1995-05-16

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K950393 for ACE(TM) CEDIA(R) FERRITIN ASSAY, Substantially Equivalent on 1995-05-16. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1995-02-01
Decision date: 1995-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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