Opus(R) Tobramycin

FDA 510(k) K911940 · Pb Diagnostic Systems, Inc.

Substantially Equivalent

510(k) numberK911940

Submission

Device name
Opus(R) Tobramycin
Applicant
Pb Diagnostic Systems, Inc.
Westwood, MA, US
Received
May 1, 1991
Decision date
July 1, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LCR – Fluorescent Immunoassay, Tobramycin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3900
Specialty
Clinical Toxicology

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K911613Var Aural Grom AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4LCR · Traditional Exmoor Plastics , Ltd.06/28/1991SE
K854873Intraocular Pressure ReducerLCR · Traditional Mira, Inc.02/04/1986SE
K850058Du Pont Tobramycin Assay ReagentsLCR · Traditional E.I. Dupont DE Nemours & Co., Inc.01/18/1985SE
K840847Immpulse Tobramycin Assay ReagentsLCR · Traditional Paragon Diagnostics, Inc.04/04/1984SE
K832408Stratus Tobramycin Fluorometric EnzymLCR · Traditional American Dade08/26/1983SE
K822197Needle HoldersLCR · Traditional Kelleher Corp.08/16/1982SE

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Questions and answers

When was Opus(R) Tobramycin cleared by the FDA?

Opus(R) Tobramycin (K911940) received a 510(k) decision of Substantially Equivalent on July 1, 1991, 61 days after the submission was received.

What is the product code of K911940?

The FDA product code is LCR – Fluorescent Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.