Cleared Traditional

K812487 - IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
(FDA 510(k) Clearance)

K812487 · Dako Corp. · Immunology

Sep 1981

Decision

23d

Days

Class 2

Risk

K812487 is an FDA 510(k) clearance for the IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM, a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DAO), submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 23 days after receiving the submission on August 31, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number	K812487 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1981
Decision Date	September 23, 1981
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—