Cleared Traditional

MYCO-FLUOR REAGENT A & B

K874662 · Scott Laboratories, Inc. · Pathology
Nov 1987
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K874662 is an FDA 510(k) clearance for the MYCO-FLUOR REAGENT A & B, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Scott Laboratories, Inc. (Sulphur, US). The FDA issued a Cleared decision on November 25, 1987, 12 days after receiving the submission on November 13, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K874662 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1987
Decision Date November 25, 1987
Days to Decision 12 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