Imipenem Susceptibility Powder

FDA 510(k) K855071 · Merck, Sharp & Dohme

Substantially Equivalent

510(k) numberK855071

Submission

Device name
Imipenem Susceptibility Powder
Applicant
Merck, Sharp & Dohme
West Point, PA, US
Received
December 19, 1985
Decision date
March 6, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JTT – Susceptibility Test Powders, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Specialty
Microbiology

Other 510(k)s with product code JTT

510(k)DeviceApplicantDecision
K983310Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional Accumed Intl., Inc.12/17/1998SE
K935805Pasco Mic and Mic/Id PanelsJTT · Traditional Pasco Laboratories, Inc.06/13/1994SE
K895362Bactec Pyrazinamide Susceptibility TestJTT · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic12/01/1989SE
K880574Modified Imipenem Susceptibility PowderJTT · Traditional Merck, Sharp & Dohme05/04/1988SE
K872081Cipro (TM) Diagnostic PowderJTT · Traditional Miles Pharmaceuticals06/15/1987SE
K864442Norfloxacin Susceptibility PowderJTT · Traditional Merck, Sharp & Dohme12/11/1986SE
K860031Gen Diagnostics' Imipenem 10 MCG Susceptibity DiskJTT · Traditional Organon Teknika Corp.03/06/1986SE
K855207Imipenem 10 MCG Sensitivity DiscsJTT · Traditional Difco Laboratories, Inc.03/06/1986SE
K855106Imipenem 10 MCG Sensi-Disc,Cat. # 31644/31645JTT · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic03/06/1986SE
K830758Azlin Azlocilin Sodium-Diag. ReagentJTT · Traditional Miles Laboratories, Inc.05/25/1983SE

More from Miles Laboratories, Inc.

510(k)DeviceDecision
K880574Modified Imipenem Susceptibility PowderJTT · Traditional 05/04/1988SE
K864442Norfloxacin Susceptibility PowderJTT · Traditional 12/11/1986SE
K760605Lightcast II Carbide BladeGES · Traditional 10/05/1976SE

Questions and answers

When was Imipenem Susceptibility Powder cleared by the FDA?

Imipenem Susceptibility Powder (K855071) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 77 days after the submission was received.

What is the product code of K855071?

The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.