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FDA 510(k)

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY

K-Number: K081522 · 2008-12-05

ApplicantBio Nuclear Diagnostics, Inc.
Decision Date2008-12-05
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Bio Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K081522. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY?

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Bio Nuclear Diagnostics, Inc.. The 510(k) number is K081522.

When did BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY receive FDA 510(k) clearance?

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY received FDA 510(k) clearance on 2008-12-05, under 510(k) number K081522.

Who is the listed applicant for BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY?

The FDA 510(k) record lists Bio Nuclear Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY?

The FDA product code for BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY is HHT.

Related Clinical Trials

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Related Devices (Code: HHT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK072381SOFTPAP CERVICAL CELL COLLECTORCytocore, Inc.K062433DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEMDiamics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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