DIAMEDIX IS-MEASLES IGG TEST SYSTEM— 510(k) K974552

Name: FDA 510(k) clearance K974552
Creator: U.S. Food and Drug Administration
Published: 1998-01-28

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K974552 for DIAMEDIX IS-MEASLES IGG TEST SYSTEM, Substantially Equivalent on 1998-01-28. Applicant: Diamedix Corp.. Device class: 1.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LJB
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1997-12-04
Decision date: 1998-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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