PROGENE MICROALBUMINURIA SCREEN— 510(k) K882538

Substantially Equivalent

Progene Corp.

FDA 510(k) clearance K882538 for PROGENE MICROALBUMINURIA SCREEN, Substantially Equivalent on 1989-03-13. Applicant: Progene Corp.. Device class: 1.

Clearance details

Applicant: Progene Corp.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1988-06-21
Decision date: 1989-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIR

K222921 — Minuteful-kidney test2023-09-08
K210069 — Minuteful - kidney test2022-07-06
K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)2015-04-30
K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS2007-01-26
K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-252002-08-23

More clearances from Progene Corp.

K895294 — PROGENE IGE BEAD EIA1989-09-21
K875125 — PROGENE(TM) IGE TEST1988-02-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.