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Angel Wing Sets Modified

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922468

by Mbo Laboratories, Inc.

Identifiers

510(k) Number
K922468 FDA 510(k)
FDA Product Code
GIM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1675 FDA 510(k)
Regulation Number
862.1675 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Angel Wing Sets Modified are vacuum sample tubes with anticoagulant used for the collection of blood specimens. These devices are classified under regulation number 862.1675 for use in clinical chemistry applications.

This device is identified by FDA 510(k) number K922468. It is manufactured by Mbo Laboratories, Inc. and was cleared for market under a traditional 510(k) submission.

Frequently asked questions

What is the primary purpose of the Angel Wing Sets Modified?

These devices are vacuum sample tubes that contain an anticoagulant. They are specifically intended for the collection of blood specimens for use in clinical chemistry applications.

Under what regulatory classification are these tubes categorized?

The Angel Wing Sets Modified are classified under regulation number 862.1675, which pertains to vacuum sample tubes with anticoagulant used in clinical chemistry.

How was this device authorized for market?

The device was cleared for market by the FDA through a traditional 510(k) submission process, identified by the 510(k) number K922468.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ANGEL WING SETS -- MODIFIED (K922468) — FDA 510(k) | Innolitics, ANGEL WING SETS -- MODIFIED 510 (k) K922468 - FDA.report, Mbo-Laboratories FDA Filings - FDA.report, FDA Browser - Cleared 510 (K) - ANGEL WING SAFETY BLOOD COLLECTION WITH ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mbo Laboratories, Inc.

Sources (1)

  • FDA 510(k) K922468 24 fields · synced Sep 22, 2026