DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM— 510(k) K001875

Name: FDA 510(k) clearance K001875
Creator: U.S. Food and Drug Administration
Published: 2000-08-21

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K001875 for DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM, Substantially Equivalent on 2000-08-21. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2000-06-20
Decision date: 2000-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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