Cleared Traditional

QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT

K852999 · Kallestad Laboratories, Inc. · Immunology
Oct 1985
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K852999 is an FDA 510(k) clearance for the QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 21, 1985, 98 days after receiving the submission on July 15, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K852999 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1985
Decision Date October 21, 1985
Days to Decision 98 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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