Cleared Traditional

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M

K884147 · Orion Diagnostica, Inc. · Chemistry
Oct 1988
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K884147 is an FDA 510(k) clearance for the IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 27, 1988, 24 days after receiving the submission on October 3, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K884147 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1988
Decision Date October 27, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DFT — Igm, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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