Progene Microalbuminuria Screen

FDA 510(k) K882538 · Progene Corp.

Substantially Equivalent

510(k) numberK882538

Submission

Device name
Progene Microalbuminuria Screen
Applicant
Progene Corp.
Overland Park, KS, US
Received
June 21, 1988
Decision date
March 13, 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

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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

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K895294Progene Ige Bead EiaDGC · Traditional 09/21/1989SE
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Questions and answers

When was Progene Microalbuminuria Screen cleared by the FDA?

Progene Microalbuminuria Screen (K882538) received a 510(k) decision of Substantially Equivalent on March 13, 1989, 265 days after the submission was received.

What is the product code of K882538?

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.