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FDA 510(k)

DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM

K-Number: K062433 · 2007-03-16

ApplicantDiamics, Inc.
Decision Date2007-03-16
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamics, Inc.. It received FDA 510(k) clearance on 2007-03-16 under 510(k) number K062433. 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 DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM?

DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-16. The listed applicant is Diamics, Inc.. The 510(k) number is K062433.

When did DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM receive FDA 510(k) clearance?

DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM received FDA 510(k) clearance on 2007-03-16, under 510(k) number K062433.

Who is the listed applicant for DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM?

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

What is the FDA product code for DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM?

The FDA product code for DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM is HHT.

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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 GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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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