Ria/Mat Fpa Test Kit

FDA 510(k) K884496 · Altana, Inc.

Substantially Equivalent

510(k) numberK884496

Submission

Device name
Ria/Mat Fpa Test Kit
Applicant
Altana, Inc.
Melville, NY, US
Received
October 25, 1988
Decision date
November 16, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DAN – Fibrinopeptide A, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5350
Specialty
Immunology

Other 510(k)s with product code DAN

510(k)DeviceApplicantDecision
K854384Asserachrom Fpa KitDAN · Traditional American Bioproducts Co.02/04/1986SE
K821151Ria-Quant Fpa Test KitDAN · Traditional Mallinckrodt Critical Care07/22/1982SE

More from Mallinckrodt Critical Care

510(k)DeviceDecision
K934205Search-SonicIYO · Traditional 06/21/1994SE

Questions and answers

When was Ria/Mat Fpa Test Kit cleared by the FDA?

Ria/Mat Fpa Test Kit (K884496) received a 510(k) decision of Substantially Equivalent on November 16, 1988, 22 days after the submission was received.

What is the product code of K884496?

The FDA product code is DAN – Fibrinopeptide A, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5350.