Cleared Traditional

ALLERGAN IMMUNO CAP M4, M8, K70

K974350 · Pharmacia, Inc. · Immunology
Feb 1998
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K974350 is an FDA 510(k) clearance for the ALLERGAN IMMUNO CAP M4, M8, K70, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on February 9, 1998, 82 days after receiving the submission on November 19, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K974350 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1997
Decision Date February 09, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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