Cleared Traditional

N-ASSAY TIA IGG

K933972 · Crestat Diagnostics, Inc. · Immunology
Mar 1994
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K933972 is an FDA 510(k) clearance for the N-ASSAY TIA IGG, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Crestat Diagnostics, Inc. (Thousand Oaks, US). The FDA issued a Cleared decision on March 22, 1994, 221 days after receiving the submission on August 13, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K933972 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1993
Decision Date March 22, 1994
Days to Decision 221 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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