Cleared Traditional

ALTERNATE PROCEDURE, PHARMACIA IGE EIA

K882616 · Pharmacia, Inc. · Immunology
Aug 1988
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K882616 is an FDA 510(k) clearance for the ALTERNATE PROCEDURE, PHARMACIA IGE EIA, a Radioimmunoassay, Immunoglobulins (d, E) (Class II — Special Controls, product code JHR), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on August 4, 1988, 41 days after receiving the submission on June 24, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K882616 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1988
Decision Date August 04, 1988
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JHR — Radioimmunoassay, Immunoglobulins (d, E)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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