LifeGlobal Micro Tips

FDA 510(k) K152581 · Life Global Group, LLC

Substantially Equivalent

510(k) numberK152581

Submission

Device name
LifeGlobal Micro Tips
Applicant
Life Global Group, LLC
Gilford, CT, US
Received
September 10, 2015
Decision date
April 11, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MQH – Microtools, Assisted Reproduction (Pipettes)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6130
Specialty
Obstetrics/Gynecology

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More from Mid-Atlantic Diagnostics, Inc.

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Questions and answers

When was LifeGlobal Micro Tips cleared by the FDA?

LifeGlobal Micro Tips (K152581) received a 510(k) decision of Substantially Equivalent on April 11, 2016, 214 days after the submission was received.

What is the product code of K152581?

The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.