Cleared Traditional

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT

K870089 · Microscan Div. Baxter Healthcare Corp. · Microbiology
Mar 1987
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K870089 is an FDA 510(k) clearance for the IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT, a Antisera, All Groups, N. Meningitidis (Class II — Special Controls, product code GTJ), submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on March 17, 1987, 67 days after receiving the submission on January 9, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K870089 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1987
Decision Date March 17, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GTJ — Antisera, All Groups, N. Meningitidis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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