Cleared Traditional

HUMAN AB SERUM - STERILE FILTERED

K861813 · Hazleton Research Products, Inc. · Pathology
May 1986
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K861813 is an FDA 510(k) clearance for the HUMAN AB SERUM - STERILE FILTERED, a Sera, Animal And Human (Class I — General Controls, product code KIS), submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on May 20, 1986, 11 days after receiving the submission on May 9, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.

Submission Details

510(k) Number K861813 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1986
Decision Date May 20, 1986
Days to Decision 11 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIS — Sera, Animal And Human
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2800

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