Cleared Traditional

WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR

K944664 · Wako Chemicals USA, Inc. · Chemistry
Feb 1995
Decision
138d
Days
Class 1
Risk

About This 510(k) Submission

K944664 is an FDA 510(k) clearance for the WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on February 7, 1995, 138 days after receiving the submission on September 22, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K944664 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1994
Decision Date February 07, 1995
Days to Decision 138 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

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