Gamma Stick Gentamicin Ria Kit

FDA 510(k) K800537 · Alpha Gamma Laboratory

Substantially Equivalent

510(k) numberK800537

Submission

Device name
Gamma Stick Gentamicin Ria Kit
Applicant
Alpha Gamma Laboratory
Mchenry, IL, US
Received
March 10, 1980
Decision date
April 24, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DJB – Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3450
Specialty
Clinical Toxicology

Other 510(k)s with product code DJB

510(k)DeviceApplicantDecision
K832792Ames Tda Sisomicin Test-Control SerumDJB · Traditional Miles Laboratories, Inc.09/29/1983SE
K831210Gentamicin Test Pack-AcaDJB · Traditional E.I. Dupont DE Nemours & Co., Inc.05/25/1983SE
K821669Ames Tda Gentamicin TestDJB · Traditional Miles Laboratories, Inc.12/15/1982SE
K812394MRI Gentamicin Ria KitDJB · Traditional Microanalytic Research, Inc.09/08/1981SE
K811844Coat-A-Count Gentamicin Ria KitDJB · Traditional Diagnostic Products Corp.07/10/1981SE
K791770Quantimune Gentamicin Ria GentamicinDJB · Traditional Bio-Rad10/17/1979SE
K791547Fluoromatic Gentamicin Fia ImmunoassayDJB · Traditional Bio-Rad10/12/1979SE
K782049Bioassay System, MS-2 SerumDJB · Traditional Abbott Laboratories08/28/1979SE
K790584Ames Tda/GentgmicinDJB · Traditional Miles Laboratories, Inc.06/15/1979SE
K790829Emit Gentamicin AssayDJB · Traditional Syva Co.05/15/1979SE

More from Syva Co.

510(k)DeviceDecision
K810011Gamma Stick 125-1 Tobramycin Ria KitKLB · Traditional 01/28/1981SE
K800538Gamma Stick Cortisol Ria Kit/Stick KitCGR · Traditional 04/24/1980SE
K780492Gamma Stik 125I T3 Uptake KitCDP · Traditional 04/28/1978SE

Questions and answers

When was Gamma Stick Gentamicin Ria Kit cleared by the FDA?

Gamma Stick Gentamicin Ria Kit (K800537) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 45 days after the submission was received.

What is the product code of K800537?

The FDA product code is DJB – Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3450.