Cleared Traditional

MODIFICATION OF SEROCARD RUBELLA IGG TEST

K902571 · Disease Detection International, Inc. · Microbiology
Sep 1990
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K902571 is an FDA 510(k) clearance for the MODIFICATION OF SEROCARD RUBELLA IGG TEST, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on September 5, 1990, 90 days after receiving the submission on June 7, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K902571 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1990
Decision Date September 05, 1990
Days to Decision 90 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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