Cleared Traditional

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

K884040 · Orion Diagnostica, Inc. · Immunology
Oct 1988
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K884040 is an FDA 510(k) clearance for the IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A, a Iga, Antigen, Antiserum, Control (Class II — Special Controls, product code CZP), submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 19, 1988, 23 days after receiving the submission on September 26, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K884040 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1988
Decision Date October 19, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZP — Iga, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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