Cleared Traditional

SPIFE IFE CALIBRATOR AND CONTROL KIT

K010617 · Helena Laboratories · Immunology
Mar 2001
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K010617 is an FDA 510(k) clearance for the SPIFE IFE CALIBRATOR AND CONTROL KIT, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on March 15, 2001, 14 days after receiving the submission on March 1, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K010617 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2001
Decision Date March 15, 2001
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEW — Igg, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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