Cleared Traditional

NEPHELRATE ANTISERUMS, IGG

K781656 · Antibodies, Inc. · Immunology
Nov 1978
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K781656 is an FDA 510(k) clearance for the NEPHELRATE ANTISERUMS, IGG, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978, 42 days after receiving the submission on September 27, 1978. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K781656 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1978
Decision Date November 08, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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