Cleared Traditional

QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT

K841864 · Kallestad Laboratories, Inc. · Immunology
Jul 1984
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K841864 is an FDA 510(k) clearance for the QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by Kallestad Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on July 11, 1984, 68 days after receiving the submission on May 4, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K841864 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1984
Decision Date July 11, 1984
Days to Decision 68 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DEH — Lambda, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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