Cleared Traditional

ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI

K790712 · Kent Laboratories, Inc. · Immunology
Aug 1979
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K790712 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979, 126 days after receiving the submission on April 12, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number K790712 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1979
Decision Date August 16, 1979
Days to Decision 126 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDB — Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5210

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