Cleared Traditional

ANIMAL AND HUMAN SERA

K881287 · Cell Culture Laboratories · Pathology

Apr 1988

Decision

Days

Class 1

Risk

About This 510(k) Submission

K881287 is an FDA 510(k) clearance for the ANIMAL AND HUMAN SERA, a Sera, Animal And Human (Class I — General Controls, product code KIS), submitted by Cell Culture Laboratories (Cleveland, US). The FDA issued a Cleared decision on April 5, 1988, 8 days after receiving the submission on March 28, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number	K881287 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 1988
Decision Date	April 05, 1988
Days to Decision	8 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—