LYME DISEASE MICROASSAY— 510(k) K890843

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K890843 for LYME DISEASE MICROASSAY, Substantially Equivalent on 1989-07-25. 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: 1989-02-21
Decision date: 1989-07-25
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.