Cleared Traditional

HAEMOPHILUS/NEISSERIA IDENTIF-PANEL

K833027 · American Micro Scan · Microbiology
Oct 1983
Decision
51d
Days
Risk

About This 510(k) Submission

K833027 is an FDA 510(k) clearance for the HAEMOPHILUS/NEISSERIA IDENTIF-PANEL, submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 51 days after receiving the submission on September 7, 1983. This device falls under the Microbiology review panel.

Submission Details

510(k) Number K833027 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1983
Decision Date October 28, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code
Device Class