Cleared Traditional

TOBRAMYCIN REAGENT

K832763 · Biosan Laboratories, Inc. · Chemistry
Mar 1984
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K832763 is an FDA 510(k) clearance for the TOBRAMYCIN REAGENT, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Biosan Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 220 days after receiving the submission on August 16, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K832763 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1983
Decision Date March 23, 1984
Days to Decision 220 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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