Cleared Traditional

RUBELLA IGG ELISA TEST

K941624 · Gull Laboratories, Inc. · Microbiology
Aug 1995
Decision
487d
Days
Class 2
Risk

About This 510(k) Submission

K941624 is an FDA 510(k) clearance for the RUBELLA IGG ELISA TEST, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 4, 1995, 487 days after receiving the submission on April 4, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K941624 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1994
Decision Date August 04, 1995
Days to Decision 487 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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