Cleared Traditional

PLATELIA RUBELLA IGG KIT

K894946 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology
Dec 1989
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K894946 is an FDA 510(k) clearance for the PLATELIA RUBELLA IGG KIT, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on December 21, 1989, 140 days after receiving the submission on August 3, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K894946 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1989
Decision Date December 21, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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