Cleared Traditional

EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY

K882294 · Syva Co. · Toxicology
Jul 1988
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K882294 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 1, 1988, 29 days after receiving the submission on June 2, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K882294 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1988
Decision Date July 01, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLB — Radioimmunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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