Cleared Traditional

PLATELIA TOXO IGG KIT

K894947 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology
Mar 1990
Decision
232d
Days
Class 1
Risk

About This 510(k) Submission

K894947 is an FDA 510(k) clearance for the PLATELIA TOXO IGG KIT, a Test, Leukocyte Typing (Class I — General Controls, product code LGO), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 23, 1990, 232 days after receiving the submission on August 3, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.7675.

Submission Details

510(k) Number K894947 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1989
Decision Date March 23, 1990
Days to Decision 232 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LGO — Test, Leukocyte Typing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.7675