Roentgenography Set

FDA 510(k) K830229 · Mallinckrodt Critical Care

Substantially Equivalent

510(k) numberK830229

Submission

Device name
Roentgenography Set
Applicant
Mallinckrodt Critical Care
Walker, MI, US
Received
January 24, 1983
Decision date
March 9, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DGD – Igg, Ferritin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

Other 510(k)s with product code DGD

510(k)DeviceApplicantDecision
K946266Ferritin Control - Level 1, 2, 3DGD · Traditional Clinical Controls, Inc.02/10/1995SE
K881345Imx FerritinDGD · Traditional Abbott Laboratories05/11/1988SE

More from Abbott Laboratories

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K874514Hi-Lo Temp(R) General Purpose Temperature ProbeFLL · Traditional 01/29/1988SE
K874568Hi-Lo Temp(R) Model 8700 Patient Temp MonitorFLL · Traditional 01/06/1988SE
K874404Hi-Lo Temp(R) Skin Temperature SensorFLL · Traditional 11/06/1987SE
K873461Laser-Flex(Tm) Tracheal Tube (Cuffed)BTR · Traditional 11/06/1987SE
K873833Thermocouple AdapterFLL · Traditional 11/03/1987SE
K873004Guiding CatheterDQO · Traditional 09/15/1987SE
K871204Cuffed Tracheal Tube (Multiple)BTR · Traditional 04/21/1987SE
K862666Uncuffed Laser Resisteant Tracheal Tube(Tentative)BTR · Traditional 08/01/1986SE

Questions and answers

When was Roentgenography Set cleared by the FDA?

Roentgenography Set (K830229) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 44 days after the submission was received.

What is the product code of K830229?

The FDA product code is DGD – Igg, Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.