Cleared Traditional

SPOTTEST LOEFFLER METHYLENE BLUE STAIN

K843919 · Difco Laboratories, Inc. · Microbiology
Oct 1984
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K843919 is an FDA 510(k) clearance for the SPOTTEST LOEFFLER METHYLENE BLUE STAIN, a Methylene Blue, Tissue Stain (Class I — General Controls, product code KFC), submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on October 30, 1984, 25 days after receiving the submission on October 5, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K843919 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1984
Decision Date October 30, 1984
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KFC — Methylene Blue, Tissue Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850