Cleared Traditional

IMMPULSE T4 ASSAY REAGENTS

K875081 · Sclavo, Inc. · Toxicology
Feb 1988
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K875081 is an FDA 510(k) clearance for the IMMPULSE T4 ASSAY REAGENTS, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 11, 1988, 64 days after receiving the submission on December 9, 1987. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K875081 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1987
Decision Date February 11, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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