Cleared Traditional

SPIFE URINE IFE

K982639 · Helena Laboratories · Immunology
Nov 1998
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K982639 is an FDA 510(k) clearance for the SPIFE URINE IFE, a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DAO), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 4, 1998, 98 days after receiving the submission on July 29, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K982639 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1998
Decision Date November 04, 1998
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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