Cleared Traditional

K812847 - XYLENE
(FDA 510(k) Clearance)

K812847 · Richard-Allan Medical Ind., Inc. · Hematology device

Oct 1981

Decision

20d

Days

Class 1

Risk

K812847 is an FDA 510(k) clearance for the XYLENE. This device is classified as a Agent, Clearing (Class I - General Controls, product code KEM).

Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 29, 1981, 20 days after receiving the submission on October 9, 1981.

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

Submission Details

510(k) Number	K812847 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 09, 1981
Decision Date	October 29, 1981
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—