Cleared Traditional

MLC NORMAL SERUM

K870580 · Rjo Biologicals, Inc. · Pathology

Apr 1987

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K870580 is an FDA 510(k) clearance for the MLC NORMAL SERUM, a Sera, Animal And Human (Class I — General Controls, product code KIS), submitted by Rjo Biologicals, Inc. (Kansas City, US). The FDA issued a Cleared decision on April 8, 1987, 56 days after receiving the submission on February 11, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number	K870580 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 1987
Decision Date	April 08, 1987
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—