Cleared Traditional

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

K971458 · Diagnostic Specialties · Chemistry

Sep 1997

Decision

133d

Days

Class 1

Risk

About This 510(k) Submission

K971458 is an FDA 510(k) clearance for the ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on September 2, 1997, 133 days after receiving the submission on April 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K971458 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1997
Decision Date	September 02, 1997
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	JIQ — Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1645