Cleared Traditional

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA

K033786 · Ibl GmbH · Chemistry
Feb 2004
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K033786 is an FDA 510(k) clearance for the LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on February 27, 2004, 85 days after receiving the submission on December 4, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K033786 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2003
Decision Date February 27, 2004
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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