Cleared Traditional

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

K854447 · American Micro Scan · Microbiology
Jan 1986
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K854447 is an FDA 510(k) clearance for the IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on January 3, 1986, 59 days after receiving the submission on November 5, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K854447 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1985
Decision Date January 03, 1986
Days to Decision 59 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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