BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY— 510(k) K081522

Name: FDA 510(k) clearance K081522
Creator: U.S. Food and Drug Administration
Published: 2008-12-05

Substantially Equivalent

Bio Nuclear Diagnostics, Inc.

FDA 510(k) clearance K081522 for BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY, Substantially Equivalent on 2008-12-05. Applicant: Bio Nuclear Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Bio Nuclear Diagnostics, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2008-05-30
Decision date: 2008-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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