Amikacin Kit (Fpia)

FDA 510(k) K862248 · Windsor Laboratories, Inc.

Substantially Equivalent

510(k) numberK862248

Submission

Device name
Amikacin Kit (Fpia)
Applicant
Windsor Laboratories, Inc.
Garland, TX, US
Received
June 12, 1986
Decision date
August 4, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LGJ – Fluorescence Polarization Immunoassay, Amibacin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3035
Specialty
Clinical Toxicology

Other 510(k)s with product code LGJ

510(k)DeviceApplicantDecision
K991597Cobas Integra Amikacin MabLGJ · Traditional Roche Diagnostics Corp.07/22/1999SE
K941712Cobas-Fp Reagents and CalibratorsLGJ · Traditional Roche Diagnostic Systems, Inc.06/13/1994SE

More from Roche Diagnostic Systems, Inc.

510(k)DeviceDecision
K873281Carbamazepine (Fpia) Calibrator KitDLJ · Traditional 10/28/1987SE
K873282Carbamazepine Fpia Fluores. Polariza. ImmunoassayKLT · Traditional 09/22/1987SE
K871486(Fpia) Assay BufferJJF · Traditional 05/08/1987SE
K870390Phenobarbital (Fpia) Calibrator KitDLJ · Traditional 04/01/1987SE
K870389Digoxin (Fpia) Calibrator KitDLJ · Traditional 04/01/1987SE
K864333Digoxin Fpia Fluorescence Polarization ImmunoassayKXT · Traditional 01/05/1987SE
K863625Phenobarbital-Fpia Fluores. Polar. Immunoassay KitLGQ · Traditional 11/10/1986SE
K863244Amikacin (Fpia) Calibrator KitDLJ · Traditional 08/29/1986SE
K861891Tobramycin (Fpia) Calibrator KitJIS · Traditional 06/25/1986SE
K861770Phenytoin (Fpia) Calibrator KitJIS · Traditional 06/25/1986SE

Questions and answers

When was Amikacin Kit (Fpia) cleared by the FDA?

Amikacin Kit (Fpia) (K862248) received a 510(k) decision of Substantially Equivalent on August 4, 1986, 53 days after the submission was received.

What is the product code of K862248?

The FDA product code is LGJ – Fluorescence Polarization Immunoassay, Amibacin, a Class II (moderate risk) device regulated under 21 CFR 862.3035.