Angel Wing Sets -- Modified

FDA 510(k) K922468 · Mbo Laboratories, Inc.

Substantially Equivalent

510(k) numberK922468

Submission

Device name
Angel Wing Sets -- Modified
Applicant
Mbo Laboratories, Inc.
North Chelmsford, MA, US
Received
May 13, 1992
Decision date
July 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GIM – Tubes, Vacuum Sample, With Anticoagulant
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Specialty
Clinical Chemistry

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K971449Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)GIM · Traditional Becton Dickinson Vacutainer Systems06/17/1997SE
K971221Greiner Vacuette Blood Collection TubeGIM · Traditional Greiner America, Inc.05/02/1997SE
K951886Lok-On Needle Disposal SystemGIM · Traditional Becton Dickinson Vacutainer Systems06/30/1995SE
K945458Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic02/06/1995SE

More from Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k)DeviceDecision
K920184Angel Wing Safety Blood Collection with Tube Hold.GIM · Traditional 02/18/1992SE
K912563Angel Wing Safety Blood Collection and Infusion SeFOZ · Traditional 10/02/1991SE

Questions and answers

When was Angel Wing Sets -- Modified cleared by the FDA?

Angel Wing Sets -- Modified (K922468) received a 510(k) decision of Substantially Equivalent on July 10, 1992, 58 days after the submission was received.

What is the product code of K922468?

The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.