INSTACCULT— 510(k) K002930

Substantially Equivalent

Medtek Diagnostics, LLC

FDA 510(k) clearance K002930 for INSTACCULT, Substantially Equivalent on 2001-01-22. Applicant: Medtek Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Medtek Diagnostics, LLC
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2000-09-20
Decision date: 2001-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, 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.