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

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..

Clearance details

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

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