Cleared Traditional

K821977 - GRAMSTAIN SET
(FDA 510(k) Clearance)

K821977 · Granite Diagnostics, Inc. · Pathology device

Jul 1982

Decision

16d

Days

Class 1

Risk

K821977 is an FDA 510(k) clearance for the GRAMSTAIN SET. This device is classified as a Iodine, Grams (Class I - General Controls, product code HYI).

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982, 16 days after receiving the submission on July 6, 1982.

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

Submission Details

510(k) Number	K821977 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 06, 1982
Decision Date	July 22, 1982
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—