Cleared Traditional

K843050 - GRAM STAIN
(FDA 510(k) Clearance)

K843050 · Reagent Laboratory, Inc. · Microbiology device

Sep 1984

Decision

39d

Days

Class 1

Risk

K843050 is an FDA 510(k) clearance for the GRAM STAIN. This device is classified as a Stains, Microbiologic (Class I - General Controls, product code JTS).

Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 39 days after receiving the submission on August 3, 1984.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K843050 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 1984
Decision Date	September 11, 1984
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—