Cleared Traditional

K864531 - TISSUE GRAM STAIN
(FDA 510(k) Clearance)

K864531 · Sigma Diagnostics, Inc. · Pathology device

Dec 1986

Decision

35d

Days

Class 1

Risk

K864531 is an FDA 510(k) clearance for the TISSUE GRAM STAIN. This device is classified as a Crystal Violet For Histology (Class I - General Controls, product code ICF).

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 22, 1986, 35 days after receiving the submission on November 17, 1986.

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

Submission Details

510(k) Number	K864531 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 1986
Decision Date	December 22, 1986
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—