Cleared Traditional

ROSCO PYRR

K894221 · Pro-Lab, Inc. · Microbiology
Sep 1989
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K894221 is an FDA 510(k) clearance for the ROSCO PYRR, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Pro-Lab, Inc. (Round Rock, US). The FDA issued a Cleared decision on September 28, 1989, 101 days after receiving the submission on June 19, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K894221 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1989
Decision Date September 28, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660