Cleared Traditional

ACCRA-LAB GRAM STAIN SET 55760

K811780 · Accra Laboratories, Inc. · Pathology
Jul 1981
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K811780 is an FDA 510(k) clearance for the ACCRA-LAB GRAM STAIN SET 55760, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981, 34 days after receiving the submission on June 23, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K811780 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1981
Decision Date July 27, 1981
Days to Decision 34 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