Cleared Traditional

ELISA RUBELLA IGM

K914420 · Sclavo, Inc. · Microbiology
Dec 1991
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K914420 is an FDA 510(k) clearance for the ELISA RUBELLA IGM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 27, 1991, 85 days after receiving the submission on October 3, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K914420 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1991
Decision Date December 27, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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