Cleared Traditional

QUANTA LITE INTRINSIC FACTOR ELISA

K061841 · Inova Diagnostics, Inc. · Immunology
Dec 2006
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K061841 is an FDA 510(k) clearance for the QUANTA LITE INTRINSIC FACTOR ELISA, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 2006, 176 days after receiving the submission on June 29, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K061841 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2006
Decision Date December 22, 2006
Days to Decision 176 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LIG — Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

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