Cleared Traditional

NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR

K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Chemistry
Mar 1990
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K897072 is an FDA 510(k) clearance for the NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 29, 1990, 97 days after receiving the submission on December 22, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K897072 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1989
Decision Date March 29, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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