Cleared Traditional

PRO DISCS

K882630 · Carr-Scarborough Microbiologicals, Inc. · Microbiology
Feb 1989
Decision
234d
Days
Class 1
Risk

About This 510(k) Submission

K882630 is an FDA 510(k) clearance for the PRO DISCS, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on February 16, 1989, 234 days after receiving the submission on June 27, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K882630 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1988
Decision Date February 16, 1989
Days to Decision 234 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