Cleared Traditional

IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE

K870029 · American Micro Scan · Microbiology
Mar 1987
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K870029 is an FDA 510(k) clearance for the IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE, a Antisera, All Types, Streptococcus Pneumoniae (Class I — General Controls, product code GWC), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on March 25, 1987, 79 days after receiving the submission on January 5, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K870029 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1987
Decision Date March 25, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GWC — Antisera, All Types, Streptococcus Pneumoniae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740