Dialbumin

FDA 510(k) K891544 · Exocell, Inc.

Substantially Equivalent

510(k) numberK891544

Submission

Device name
Dialbumin
Applicant
Exocell, Inc.
Philadelphia, PA, US
Received
March 17, 1989
Decision date
June 9, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device class
Class I (low risk)
Regulation
21 CFR 862.1645
Specialty
Clinical Chemistry

Other 510(k)s with product code JIR

510(k)DeviceApplicantDecision
K222921Minuteful-kidney testJIR · Traditional Healthy.Io, Ltd.09/08/2023SE
K210069Minuteful - kidney testJIR · Traditional Healthy.Io, Ltd.07/06/2022SE
K150330Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR · Traditional ACON Laboratories, Inc.04/30/2015SE
K061419Teco Microalbumin 2-1 Combo StripsJIR · Traditional Teco Diagnostics01/26/2007SE
K022538Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special Diagnostic Chemicals, Ltd. (Usa)08/23/2002SE
K001810Urisite Urine Collection Kit for Microalbumin/Creatinine TestingJIR · Traditional Flexsite Diagnostics, Inc.08/14/2000SE
K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional Diagnostic Chemicals , Ltd.02/01/2000SE
K992257New Multiples Reagent StripsJIR · Traditional Bayer Corp.11/24/1999SE
K991315Microalbustix Reagent Strips (OTC)JIR · Traditional Bayer Corp.11/12/1999SE
K983774UalbJIR · Traditional Abbott Laboratories01/28/1999SE

More from Abbott Laboratories

510(k)DeviceDecision
K980888GlycacorLCP · Traditional 08/13/1998SE
K894423Acc.U.DialJJQ · Traditional 12/27/1989SE
K893453GlycabenLCP · Traditional 10/23/1989SE
K884146AlbuwellJIR · Traditional 01/23/1989SE

Questions and answers

When was Dialbumin cleared by the FDA?

Dialbumin (K891544) received a 510(k) decision of Substantially Equivalent on June 9, 1989, 84 days after the submission was received.

What is the product code of K891544?

The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.