Tobramycin Fpia Reagent Set and Calibrator

Q: What is the product code of K944371?

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

FDA 510(k) K944371 · Sigma Diagnostics, Inc.

Substantially Equivalent

510(k) numberK944371

Submission

Device name: Tobramycin Fpia Reagent Set and Calibrator
Applicant: Sigma Diagnostics, Inc.
St. Louis, MO, US
Received: September 7, 1994
Decision date: November 10, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LFW – Fluorescence Polarization Immunoassay, Tobramycin
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.3900
Specialty: Clinical Toxicology

Other 510(k)s with product code LFW

510(k)	Device	Applicant	Decision
K964670	Roche Cobas-Fp Reagents for TobramycinLFW · Traditional	Roche Diagnostic Systems, Inc.	02/04/1997SE
K941614	Axsym TobramycinLFW · Traditional	Abbott Laboratories	08/18/1994SE
K912143	Cedia(R) Tobramycin AssayLFW · Traditional	Microgenics Corp.	07/26/1991SE
K900707	Modified Accufluor Tobramycin Reagent & CalibratorLFW · Traditional	Innotron of Oregon, Inc.	04/20/1990SE
K894531	FPR Tobramycin KitLFW · Traditional	Colony Laboratories, Inc.	09/01/1989SE
K872562	Innotron Innofluor Tobramycin Reagent SetLFW · Traditional	Innotron of Oregon, Inc.	08/17/1987SE
K854392	Tobramycin Kit(Fpia)Fluorescence Polarization ImmuLFW · Traditional	Windsor Laboratories, Inc.	12/05/1985SE
K843828	Cobas Reagents for Tobramycin & CalibraLFW · Traditional	Roche Diagnostic Systems, Inc.	02/01/1985SE
K841866	Innoflour TobramycinLFW · Traditional	Innotron Diagnostics	05/31/1984SE

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Questions and answers

When was Tobramycin Fpia Reagent Set and Calibrator cleared by the FDA?

Tobramycin Fpia Reagent Set and Calibrator (K944371) received a 510(k) decision of Substantially Equivalent on November 10, 1994, 64 days after the submission was received.

What is the product code of K944371?

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