Cleared Traditional

ALBUMIN REAGENT

K890333 · Alpkem Corp. · Chemistry
Feb 1989
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K890333 is an FDA 510(k) clearance for the ALBUMIN REAGENT, a Probe, Periodontic (Class I — General Controls, product code EIX), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on February 17, 1989, 25 days after receiving the submission on January 23, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K890333 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1989
Decision Date February 17, 1989
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code EIX — Probe, Periodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565