Cleared Traditional

NEG COMBO BREAKPOINT PANEL POS COMBO

K854278 · American Micro Scan · Microbiology
Mar 1986
Decision
131d
Days
Class 1
Risk

About This 510(k) Submission

K854278 is an FDA 510(k) clearance for the NEG COMBO BREAKPOINT PANEL POS COMBO, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on March 4, 1986, 131 days after receiving the submission on October 24, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K854278 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1985
Decision Date March 04, 1986
Days to Decision 131 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JWX — Kit, Screening, Staphylococcus Aureus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660