Cleared Traditional

EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS

K003341 · Syva Co., Dade Behring, Inc. · Chemistry
Jan 2001
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K003341 is an FDA 510(k) clearance for the EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on January 22, 2001, 89 days after receiving the submission on October 25, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K003341 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2000
Decision Date January 22, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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