Cleared Traditional

IMMPULSE T, ASSAY REAGENTS

K881214 · Sclavo, Inc. · Toxicology
May 1988
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K881214 is an FDA 510(k) clearance for the IMMPULSE T, ASSAY REAGENTS, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 27, 1988, 67 days after receiving the submission on March 21, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K881214 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1988
Decision Date May 27, 1988
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code CDP — Radioimmunoassay, Total Triiodothyronine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1710

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