FDA 510(k)

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L

K-Number: K990941 · 1999-07-14

ApplicantHumagen Fertility Diagnostics, Inc.

Decision Date1999-07-14

Product CodeMQK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L 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 1999-07-14 under 510(k) number K990941. 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 NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L?

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Humagen Fertility Diagnostics, Inc.. The 510(k) number is K990941.

When did NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L receive FDA 510(k) clearance?

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L received FDA 510(k) clearance on 1999-07-14, under 510(k) number K990941.

Who is the listed applicant for NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L?

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 NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L?

The FDA product code for NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L 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 K000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 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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