LYME IGM MICROASSAY— 510(k) K911330

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K911330 for LYME IGM MICROASSAY, Substantially Equivalent on 1991-06-10. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1991-03-25
Decision date: 1991-06-10
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.