CYTOFLEX— 510(k) K012144

Substantially Equivalent

Unicare Biomedical, Inc.

FDA 510(k) clearance K012144 for CYTOFLEX, Substantially Equivalent on 2001-10-01. Applicant: Unicare Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Unicare Biomedical, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2001-07-10
Decision date: 2001-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.