FDA 510(k)

LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES

K-Number: K112083 · 2012-05-03

Decision Date2012-05-03

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES is the device name listed in this FDA 510(k) record. The listed applicant is <Genx> Intl., Inc.. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K112083. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES?

LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is <Genx> Intl., Inc.. The 510(k) number is K112083.

When did LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES receive FDA 510(k) clearance?

LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES received FDA 510(k) clearance on 2012-05-03, under 510(k) number K112083.

Who is the listed applicant for LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES?

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

What is the FDA product code for LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES?

The FDA product code for LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES is MQL.

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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.