Cleared Traditional

K905472 - LAP DISCS
(FDA 510(k) Clearance)

K905472 · Carr-Scarborough Microbiologicals, Inc. · Microbiology
Feb 1991
Decision
83d
Days
Class 1
Risk

K905472 is an FDA 510(k) clearance for the LAP 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 27, 1991, 83 days after receiving the submission on December 6, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K905472 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1990
Decision Date February 27, 1991
Days to Decision 83 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