FDA 510(k)

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75

K-Number: K000915 · 2000-05-12

ApplicantHumagen Fertility Diagnostics, Inc.

Decision Date2000-05-12

Product CodeMQK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 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 2000-05-12 under 510(k) number K000915. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75?

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 is a medical device that received FDA 510(k) clearance on 2000-05-12. The listed applicant is Humagen Fertility Diagnostics, Inc.. The 510(k) number is K000915.

When did PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 receive FDA 510(k) clearance?

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 received FDA 510(k) clearance on 2000-05-12, under 510(k) number K000915.

Who is the listed applicant for PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75?

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 PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75?

The FDA product code for PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 is MQK.

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Other records listing Humagen Fertility Diagnostics, Inc. as applicant

K012811BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B 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

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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.