Cleared Traditional

K811797 - EOSIN-Y
(FDA 510(k) Clearance)

K811797 · Richard-Allan Medical Ind., Inc. · Hematology device

Jul 1981

Decision

34d

Days

Class 1

Risk

K811797 is an FDA 510(k) clearance for the EOSIN-Y. This device is classified as a Eosin Y (Class I - General Controls, product code HYB).

Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981, 34 days after receiving the submission on June 24, 1981.

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

Submission Details

510(k) Number	K811797 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 1981
Decision Date	July 28, 1981
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—