Gen Diagnostics' Imipenem 10 MCG Susceptibity Disk
FDA 510(k) K860031 · Organon Teknika Corp.
510(k) numberK860031
Submission
- Device name
- Gen Diagnostics' Imipenem 10 MCG Susceptibity Disk
- Applicant
- Organon Teknika Corp.
Morris Plains, NJ, US - Received
- January 6, 1986
- Decision date
- March 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | Accumed Intl., Inc. | 12/17/1998SE |
| K935805 | Pasco Mic and Mic/Id PanelsJTT · Traditional | Pasco Laboratories, Inc. | 06/13/1994SE |
| K895362 | Bactec Pyrazinamide Susceptibility TestJTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/01/1989SE |
| K880574 | Modified Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 05/04/1988SE |
| K872081 | Cipro (TM) Diagnostic PowderJTT · Traditional | Miles Pharmaceuticals | 06/15/1987SE |
| K864442 | Norfloxacin Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 12/11/1986SE |
| K855207 | Imipenem 10 MCG Sensitivity DiscsJTT · Traditional | Difco Laboratories, Inc. | 03/06/1986SE |
| K855106 | Imipenem 10 MCG Sensi-Disc,Cat. # 31644/31645JTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/06/1986SE |
| K855071 | Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 03/06/1986SE |
| K830758 | Azlin Azlocilin Sodium-Diag. ReagentJTT · Traditional | Miles Laboratories, Inc. | 05/25/1983SE |
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|---|---|---|
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| K000378 | Bact/Alert MB Culture BottleMDB · Traditional | 03/02/2000SE |
| K994343 | Bact/Alert SVMDB · Traditional | 02/10/2000SE |
| K993423 | Bact/Alert SAMDB · Traditional | 12/15/1999SE |
| K993576 | Bact/Alert MP Process BottleMDB · Traditional | 12/14/1999SE |
| K993421 | Bact/Alert SNMDB · Traditional | 12/14/1999SE |
| K992432 | Bact/Alert FNMDB · Traditional | 09/24/1999SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | 09/15/1999SE |
| K992401 | Bact/Alert PFMDB · Traditional | 09/03/1999SE |
Questions and answers
When was Gen Diagnostics' Imipenem 10 MCG Susceptibity Disk cleared by the FDA?
Gen Diagnostics' Imipenem 10 MCG Susceptibity Disk (K860031) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 59 days after the submission was received.
What is the product code of K860031?
The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.