IS-DSDNA TEST SYSTEM— 510(k) K974694

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K974694 for IS-DSDNA TEST SYSTEM, Substantially Equivalent on 1998-03-03. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1997-12-16
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.