Asserachrom Fpa Kit

FDA 510(k) K854384 · American Bioproducts Co.

Substantially Equivalent

510(k) numberK854384

Submission

Device name
Asserachrom Fpa Kit
Applicant
American Bioproducts Co.
Parsippany, NJ, US
Received
October 30, 1985
Decision date
February 4, 1986
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
K884496Ria/Mat Fpa Test KitDAN · Traditional Altana, Inc.11/16/1988SE
K821151Ria-Quant Fpa Test KitDAN · Traditional Mallinckrodt Critical Care07/22/1982SE

More from Mallinckrodt Critical Care

510(k)DeviceDecision
K983460Star Automated Multi-Parametric AnalyzerJPA · Traditional 11/12/1998SE
K971519Asserachrom Tpa Test KitGGP · Traditional 08/19/1997SE
K964728Sta-Liatest D-Di Test KitDAP · Traditional 06/26/1997SE
K964716Sta Liatest Control [N]+[P] KitGGN · Traditional 06/26/1997SE
K964718Sta D-Di Calibrator KitDAP · Traditional 05/23/1997SE
K962675Sta - Liatest VWF Test KitGJT · Traditional 10/25/1996SE
K962671Sta-Vwf Calibrator KitGJT · Traditional 09/13/1996SE
K962674Sta - VWF Control [N]+[P] KitGGN · Traditional 07/23/1996SE
K961579Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional 07/10/1996SE
K955040At-Iii Control Plasma KitGGC · Traditional 01/31/1996SE

Questions and answers

When was Asserachrom Fpa Kit cleared by the FDA?

Asserachrom Fpa Kit (K854384) received a 510(k) decision of Substantially Equivalent on February 4, 1986, 97 days after the submission was received.

What is the product code of K854384?

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