Cleared Traditional

K781584 - GRAM STAIN KIT
(FDA 510(k) Clearance)

K781584 · Bioscientific · Pathology device

Oct 1978

Decision

22d

Days

Class 1

Risk

K781584 is an FDA 510(k) clearance for the GRAM STAIN KIT. This device is classified as a Iodine, Grams (Class I - General Controls, product code HYI).

Submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978, 22 days after receiving the submission on September 18, 1978.

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

Submission Details

510(k) Number	K781584 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 18, 1978
Decision Date	October 10, 1978
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—