Cleared Traditional

K811799 - CLEAR-MOUNT
(FDA 510(k) Clearance)

K811799 · Richard-Allan Medical Ind., Inc. · Hematology device

Jul 1981

Decision

37d

Days

Class 1

Risk

K811799 is an FDA 510(k) clearance for the CLEAR-MOUNT. This device is classified as a Mounting Media (Class I - General Controls, product code LEB).

Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1981, 37 days after receiving the submission on June 24, 1981.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K811799 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 1981
Decision Date	July 31, 1981
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—