Cleared Traditional

TWO-STEP ACID FAST BACTERIA STAIN

K851494 · Accra Laboratories, Inc. · Pathology
Apr 1985
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K851494 is an FDA 510(k) clearance for the TWO-STEP ACID FAST BACTERIA STAIN, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Accra Laboratories, Inc. (Bridgeport, US). The FDA issued a Cleared decision on April 29, 1985, 14 days after receiving the submission on April 15, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K851494 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1985
Decision Date April 29, 1985
Days to Decision 14 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