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FDA 510(k)

PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)

K-Number: K033904 · 2004-01-16

ApplicantCook Urological, Inc.
Decision Date2004-01-16
Product CodeMQH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2004-01-16 under 510(k) number K033904. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)?

PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Cook Urological, Inc.. The 510(k) number is K033904.

When did PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) receive FDA 510(k) clearance?

PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) received FDA 510(k) clearance on 2004-01-16, under 510(k) number K033904.

Who is the listed applicant for PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)?

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

What is the FDA product code for PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)?

The FDA product code for PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) is MQH.

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Related Devices (Code: MQH)

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.

K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.K192146V-DENUPETVitromed GmbHK161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments LimitedK152581LifeGlobal Micro TipsLife Global Group, LLCK151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook IncorporatedK102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, 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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