Emit Assay and Tobramycin

FDA 510(k) K832055 · Syva Co.

Substantially Equivalent

510(k) numberK832055

Submission

Device name
Emit Assay and Tobramycin
Applicant
Syva Co.
Mchenry, IL, US
Received
June 27, 1983
Decision date
August 8, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDO – Enzymatic Radiochemical Assay, Tobramycin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3900
Specialty
Clinical Toxicology

Other 510(k)s with product code LDO

510(k)DeviceApplicantDecision
K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…LDO · Traditional Ortho-Clinical Diagnostics, Inc.02/07/2005SE
K841556Heart - Aid Als, 95LDO · Traditional Cardiac Resucitator Corp.07/19/1984SE

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Questions and answers

When was Emit Assay and Tobramycin cleared by the FDA?

Emit Assay and Tobramycin (K832055) received a 510(k) decision of Substantially Equivalent on August 8, 1983, 42 days after the submission was received.

What is the product code of K832055?

The FDA product code is LDO – Enzymatic Radiochemical Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.