Cleared Traditional

GRAM STAIN SET W/STABILIZED IODINE

K843429 · Accra Laboratories, Inc. · Pathology

Sep 1984

Decision

10d

Days

Class 1

Risk

About This 510(k) Submission

K843429 is an FDA 510(k) clearance for the GRAM STAIN SET W/STABILIZED IODINE, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984, 10 days after receiving the submission on September 4, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K843429 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1984
Decision Date	September 14, 1984
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—