FDA 510(k)

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

K-Number: K012811 · 2002-02-11

ApplicantHumagen Fertility Diagnostics, Inc.

Decision Date2002-02-11

Product CodeMQH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B is the device name listed in this FDA 510(k) record. The listed applicant is Humagen Fertility Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K012811. 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 BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B?

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Humagen Fertility Diagnostics, Inc.. The 510(k) number is K012811.

When did BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B receive FDA 510(k) clearance?

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B received FDA 510(k) clearance on 2002-02-11, under 510(k) number K012811.

Who is the listed applicant for BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B?

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

What is the FDA product code for BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B?

The FDA product code for BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B is MQH.

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Other records listing Humagen Fertility Diagnostics, Inc. as applicant

K000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 K990941NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L K990847INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M K915229SEMEN ANALYSIS KIT

Related Devices (Code: MQH)

K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.K192146V-DENUPETVitromed GmbH K161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments Limited K152581LifeGlobal Micro TipsLife Global Group, LLC K151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook Incorporated K102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.

Official Source

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