Cleared Traditional

K870516 - ALBUMIN SCREEN TEST
(FDA 510(k) Clearance)

K870516 · Sclavo, Inc. · Chemistry

Oct 1987

Decision

258d

Days

Class 1

Risk

K870516 is an FDA 510(k) clearance for the ALBUMIN SCREEN TEST, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on October 20, 1987, 258 days after receiving the submission on February 4, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K870516 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1987
Decision Date	October 20, 1987
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

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