Cleared Traditional

POLIO TYPE I CF ANTIGEN, & TYPE II, III

K853278 · Hillcrest Biologicals · Microbiology
Nov 1985
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K853278 is an FDA 510(k) clearance for the POLIO TYPE I CF ANTIGEN, & TYPE II, III, a Antisera, Cf, Poliovirus 1-3 (Class I — General Controls, product code GOG), submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on November 7, 1985, 94 days after receiving the submission on August 5, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K853278 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1985
Decision Date November 07, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GOG — Antisera, Cf, Poliovirus 1-3
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405