ENZIP URINARY MICROALBUMIN TEST— 510(k) K922032

Name: FDA 510(k) clearance K922032
Creator: U.S. Food and Drug Administration
Published: 1992-07-30

Substantially Equivalent

Diagnostic Specialties

FDA 510(k) clearance K922032 for ENZIP URINARY MICROALBUMIN TEST, Substantially Equivalent on 1992-07-30. Applicant: Diagnostic Specialties. Device class: 1.

Clearance details

Applicant: Diagnostic Specialties
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1992-05-01
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Metuchen, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIR

view all

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 Diagnostic Specialties

view all

K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT1997-09-02
K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT1994-08-30
K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT1993-08-19
K831180 — PREGNA-CERT, SLIDE PREGNANCY TEST1983-05-27
K823109 — GENERIC PREGNANCY TEST1982-11-10

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