Cleared Traditional

IRISTAIN FORMULA 2, PARTS 1 AND 2

K893530 · Intl. Remote Imaging Systems · Pathology
Jun 1989
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K893530 is an FDA 510(k) clearance for the IRISTAIN FORMULA 2, PARTS 1 AND 2, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on June 13, 1989, 36 days after receiving the submission on May 8, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K893530 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1989
Decision Date June 13, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JTS — Stains, Microbiologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850