Cleared Traditional

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES

K854490 · American Micro Scan · Microbiology
Dec 1985
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K854490 is an FDA 510(k) clearance for the IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES, a Antisera, All Types, H. Influenza (Class II — Special Controls, product code GRP), submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on December 27, 1985, 45 days after receiving the submission on November 12, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K854490 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1985
Decision Date December 27, 1985
Days to Decision 45 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GRP — Antisera, All Types, H. Influenza
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3300